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. Responsiveness and Validity of the SF-36, Ankle Osteoarthritis Scale, AOFAS Ankle Hindfoot Score, and Foot Function Index in End Stage Ankle Arthritis Impact of comorbidities on the measurement of health in patients with ankle osteoarthritis. INVITED COMMENTARY: Rating the Quality of Trials in Systematic Reviews of Physical Therapy Interventions Plantar fasciitis – to jab or to support? A systematic review of the current best evidence Validation of the Foot and Ankle Outcome Score in Adult Acquired Flatfoot Deformity Validation of the Foot and Ankle Outcome Score for Hallux Rigidus Foot orthoses for adults with flexible pes planus: a systematic review The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Reliability and validity of the Foot and Ankle Outcome Score: a validation study from Iran 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 The validity and reliability of the functional rating index for evaluating low back pain in athletes. Measuring change in disability after inpatient rehabilitation: comparison of the responsiveness of the Barthel Index and the Functional Independence Measure Reliability and structural validity of the Multidimensional Fatigue Inventory (MFI) in patients with idiopathic Parkinson's disease. Functional Effect of an Ankle Foot Orthosis on Gait in Multiple Sclerosis: A Pilot Study A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events. The PROMIS of Better Outcome Assessment: Responsiveness, Floor and Ceiling Effects, and Internet Administration Sensitivity of the Ottawa rules. Which questionnaire? A psychometric evaluation of three patient-based outcome measures used to assess surgery for stress urinary incontinence. Evaluation of outcomes in chronic venous disorders of the leg: development of a scientifically rigorous, patient-reported measure of symptoms and quality of life. A psychometric validation of two brief measures to assess palliative need in patients severely affected by multiple sclerosis. PROBAST: A Tool to Assess Risk of Bias and Applicability of Prediction Model Studies: Explanation and Elaboration
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 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 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 & NA ; Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports . One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies . This paper explains the process that is used to conduct systematic review s , which includes the establishment of a protocol , comprehensive search ing , appraisal of the quality of the included studies , data extraction and meta analysis , and consideration of the clinical and research implication s of the findings . We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased ( believable ) estimate of the treatment effect . A systematic review of r and omized trials of a  cardiopulmonary physical therapy intervention is used as an example . The issue of appraisal of quality is then discussed further , with a demonstration of how one vali date d tool for quality appraisal ‐‐the PEDro scale‐‐can be used to evaluate a r and omized trial in cardiopulmonary physical therapy Background : Plantar fasciitis is a common condition routinely managed by podiatrists in the community and is widely treated conservatively . Two commonly used treatments for plantar fasciitis are customized functional foot orthoses and corticosteroid injections . While common to clinical practice , the evidence base underpinning these treatment strategies is unknown . Therefore , the aim of this systematic review was to assess the effectiveness and safety of customized functional foot orthoses and corticosteroid injections in the treatment of plantar fasciitis . Methods : A systematic literature search was conducted . Experimental studies , in English , from 1998 to 2010 were accepted for inclusion in this review . The PEDro quality assessment tool and the National Health and Medical Research Council ’s hierarchy of evidence were used to assess the quality of the included studies . Results : Six r and omized controlled trials which met the selection criteria were included in this review . Four reported on customized functional foot orthoses and 2 on corticosteroid injections . Current best available evidence highlights that both customized functional foot orthoses and corticosteroid injections can lead to a decrease in pain associated with plantar fasciitis . Additionally , customized functional foot orthoses may also provide an additional benefit in terms of increased functional ability in patients with plantar fasciitis .  Corticosteroid injections may have side effects , especially pain ( from the injection ) . Conclusion : Both customized functional foot orthoses and corticosteroid injections can lead to reduction in pain associated with plantar fasciitis . While customized functional foot orthoses may increase the functional outcomes in patients with plantar fasciitis , corticosteroid injections may have side effects ( especially pain as a result of the injection ) , which may limit its acceptability 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 Background There is a clear call for improved patient-centered outcomes . The Foot and Ankle Outcome Score ( FAOS ) is a region-specific patient-reported measure that has been vali date d for a number of foot and ankle diagnoses , but not hallux rigidus . Questions / Purpose sThe aim of this study was to vali date the FAOS in patients with hallux rigidus . Methods From 2007 to 2013 , 211 patients with hallux rigidus ( HR ) were included in the study . For the construct validity portion of the study , 125 patients completed a Short-Form 12 ( SF-12 ) and FAOS survey . Forty additional HR patients were prospect ively given question naires to assess the relevance of each FAOS question as it pertained to their HR . Reliability was assessed in 36 HR patients via administration of a second FAOS an average 1 month following the first . In 55 patients , preoperative and postoperative FAOS scores were compared to determine responsiveness . Results All FAOS subscales demonstrated moderate correlation coefficients with the physical functioning , role physical , bodily pain , and physical health component scores of the SF-12 , with all subscales demonstrating poor correlation with the SF-12 mental health-related domains . Content validity was high for all FAOS scores , with the exception of the daily activities subscale . All subscales achieved acceptable test – retest reliability with correlation coefficients of ≥0.72 . Furthermore , all subscales were rated as responsive to change in postoperative patients ( p < 0.001 ) . Conclusion This study demonstrates the acceptable construct and content validity , reliability , and responsiveness of the FAOS for hallux rigidus . Due to its broad applicability and proven validation across multiple foot and ankle pathologies , the FAOS represents a patient-centered outcome measure that can be reliably used for the assessment of patients with hallux rigidus Background Foot orthoses are widely used in the management of flexible pes planus , yet the evidence to support this intervention has not been clearly defined . This systematic review aim ed to critically appraise the evidence for the use of foot orthoses for flexible pes planus in adults . Methods Electronic data bases ( Medline , CINAHL , Cochrane , Web of science , SportD iscus , Embase ) were systematic ally search ed in June 2013 for r and omised controlled , controlled clinical and repeated measure trials where participants had identified flexible pes planus using a vali date d and reliable measure of pes planus and the intervention was a rigid or semi-rigid orthoses with the comparison being a no-orthoses ( shoes alone or flat non-posted insert ) condition . Outcomes of interest were foot pain , rearfoot kinematics , foot kinetics and physical function . Results Of the 2,211 articles identified by the search es , 13 studies met the inclusion criteria ; two were r and omised controlled trials , one was a controlled trial and 10 were repeated measure studies . Across the included studies , 59 relevant outcome measures were reported with 17 calculated as statistically significant large or medium effects observed with use of foot orthoses compared to the no orthoses condition ( SMD range 1.13 to -4.11 ) . Conclusions No high level evidence supported the use of foot orthoses for flexible pes planus . There is good to moderate level evidence that foot orthoses improve physical function ( medial-lateral sway in st and ing ( level II ) and energy cost during walking ( level III ) ) . There is low level evidence ( level IV ) that foot orthoses  improve pain , reduce rearfoot eversion , alter loading and impact forces ; and reduce rearfoot inversion and eversion moments in flexible pes planus . Well- design ed r and omised controlled trials that include appropriate sample sizes , clinical cohorts and involve a measure of symptom change are required to determine the efficacy of foot orthoses to manage adult flexible pes planus INTRODUCTION Soft tissue injuries of the leg , ankle , or foot are common and often treated by exercise . The purpose of this study was to determine the effectiveness of  exercise  for the management of soft tissue injuries of the leg , ankle , or foot . METHODS A systematic review of the literature was conducted . We search ed five data bases from 1990 to 2015 . Relevant articles were critically appraised using Scottish Intercollegiate Guidelines Network ( SIGN ) criteria . The evidence from studies with low risk of bias was synthesized using the best- evidence synthesis methodology . RESULTS We screened 7946 articles . We critically appraised ten r and omized trials and six had a low risk of bias . The evidence suggests that for recent lateral ankle sprain : 1 ) rehabilitation exercises initiated immediately post-injury are as effective as a similar program initiated one week post-injury ; and 2 ) supervised progressive exercise plus education/advice and home exercise lead to similar outcomes as education/advice and home exercise . Eccentric exercises may be more effective than an AirHeel brace but less effective than acupuncture for Achilles tendinopathy of more than two months duration . Finally , for plantar heel pain , static stretching of the calf muscles and sham ultrasound lead to similar outcomes , while static plantar fascia stretching provides short-term benefits compared to shockwave therapy . CONCLUSIONS We found little evidence to support the use of early or supervised exercise interventions for lateral ankle sprains . Eccentric exercises may provide short-term benefits over a brace for persistent Achilles tendinopathy and plantar fascia stretching provides short-term benefits for plantar heel pain The aims of this study were to culturally adapt and vali date the Persian version of Foot and Ankle Outcome Score ( FAOS ) and present data on its psychometric properties for patients with different foot and ankle problems . The Persian version of FAOS was developed after a st and ard forward – backward translation and cultural adaptation process . The sample included 93 patients with foot and ankle disorders who were asked to complete two question naires : FAOS and Short-Form 36 Health Survey ( SF-36 ) . To determine test – retest reliability , 60 r and omly chosen patients completed the FAOS again 2 to 6 days after the first administration . Test – retest reliability and internal consistency were assessed using intraclass correlation coefficient ( ICC ) and Cronbach ’s alpha , respectively . To evaluate convergent and divergent validity of FAOS compared to similar and dissimilar concepts of SF-36 , the Spearman ’s rank correlation was used . Dimensionality was determined by assessing item – subscale correlation corrected for overlap . The results of test – retest reliability show that all the FAOS subscales have a very high ICC , ranging from 0.92 to 0.96 . The minimum Cronbach ’s alpha level of 0.70 was exceeded by most subscales . The Spearman ’s correlation coefficient for convergent construct validity fell within 0.32 to 0.58 for the main hypotheses presented a priori between FAOS and SF-36 subscales . For dimensionality , the minimum Spearman ’s correlation coefficient of 0.40 was exceeded by most items . In conclusion , the results of our study show that the Persian version of FAOS seems to be suitable for Iranian patients with various foot and ankle problems especially lateral ankle sprain . Future studies are needed to establish stronger psychometric properties for patients with different foot and ankle problems 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 The purpose of the present study was to determine the reliability and validity of the Functional Rating Index ( FRI ) for athletes with low back pain ( LBP ) . In this cross-sectional and prospect i ve cohort study , the vali date d Persian FRI ( PFRI ) was tested in 100 athletes with LBP and 50 healthy athletes . From the athletes with LBP , data were recollected among 50 athletes with a 7-day interval to examine test-retest reliability . The content validity was excellent , and the athletes with LBP responded to all items with no floor or ceiling effects . The discriminative validity was supported by a statistically significant difference in PFRI total scores between the athletes with LBP and healthy athletes . The concurrent criterion validity was good ( rho = 0.72 ) . The construct , convergent validity was good ( r = 0.83 ) . The internal consistency reliability estimate was high ( Cronbach 's α = 0.90 ) . Factor analysis demonstrated a single-factor structure with an explained variance of 52.22 % . The test-retest reliability was excellent , indicated by an ICC(agreement ) of 0.97 , and the agreement observed in the Bl and and Altman plot demonstrated no systematic bias . It is concluded that the PFRI has excellent psychometric properties for assessing athletes with LBP BACKGROUND The importance of evaluating disability outcome measures is well recognised . The Functional Independence Measure ( FIM ) was developed to be a more comprehensive and “ sensitive ” measure of disability than the Barthel Index ( BI ) . Although the FIM is widely used and has been shown to be reliable and valid , there is limited information about its responsiveness , particularly in comparison with the BI . This study compares the appropriateness and responsiveness of these two disability measures in patients with multiple sclerosis and stroke . METHODS Patients with multiple sclerosis ( n=201 ) and poststroke ( n=82 ) patients undergoing inpatient neurorehabilitation  were studied . Admission and discharge scores were generated for the BI and the three scales of the FIM ( total , motor , and cognitive ) . Appropriateness of the measures to the study sample s was determined by examining score distributions , floor and ceiling effects . Responsiveness was determined using an effect size calculation . RESULTS The BI , FIM total , and FIM motor scales show good variability and have small floor and ceiling effects in the study sample s. The FIM cognitive scale showed a notable ceiling effect in patients with multiple sclerosis . Comparable effect sizes were found for the BI , and two FIM scales ( total and motor ) in both patients with multiple sclerosis and stroke patients . CONCLUSION All measures were appropriate to the study sample . The FIM cognitive scale , however , has limited usefulness as an outcome measure in progressive multiple sclerosis . The BI , FIM total , and FIM motor scales show similar responsiveness , suggesting that both the FIM total and FIM motor scales have no advantage over the BI in evaluating change INTRODUCTION The Multidimensional Fatigue Inventory ( MFI ) is commonly used in patients with Parkinson 's disease ( PD ) . However , most measurement properties have not been investigated in this population . The aim of this study was to investigate internal consistency , test-retest reliability , measurement error , structural validity , and floor and ceiling effects of the MFI in PD . METHODS Patients with PD ( N = 153 ) completed the MFI at baseline and week 3 in a r and omized clinical trial . Cronbach 's α , intraclass correlation coefficient ( ICC ) , and the smallest detectable change ( SDC ) were calculated . Bl and and Altman analysis was performed . Principal Component Analysis ( PCA ) was used to explore structural validity . Floor and ceiling effects were investigated . RESULTS Cronbach 's α for the MFI-total and subscales ranged from 0.74 ( reduced motivation ( RM ) ) to 0.92 ( MFI-total ) . ICC 's ranged from 0.65 ( mental fatigue ( MF ) to 0.81 ( physical fatigue ( PF ) ) , SDC ranged from 4 points ( PF and RM ) to 15 points ( MFI-total ) . Bl and and Altman analysis showed no systematic differences between assessment s. A floor effect was found for MF and ceiling effects for PF and reduced activity ( RA ) . A four-factor model was extracted , combining general fatigue ( GF ) and PF as one factor . CONCLUSIONS The MFI is reliable and valid to assess fatigue in patients with PD . Clinicians and research ers interested in assessing specific aspects of fatigue should consider interpreting GF and PF as one subscale measuring physical aspects of fatigue . To establish whether the MFI can detect meaningful changes , studies on anchor-based responsiveness and the minimal important change are needed in PD Sheffler LR , Hennessey MT , Knutson JS , Naples GG , Chae J : Functional effect of an ankle foot orthosis on gait in multiple sclerosis : a pilot study . Am J Phys Med Rehabil 2008;87:26–32 . Objective : The objective was to determine whether an ankle foot orthosis improves gait velocity and tasks of functional ambulation in multiple sclerosis ( MS ) . Design : This cross-sectional study enrolled 15 participants with diagnosis of MS , dorsiflexion and eversion weakness , and more than 3 mos of using a physician-prescribed ankle foot orthosis ( AFO ) .  Subject ambulation was evaluated ( 1 ) without an AFO and ( 2 ) with an AFO . Outcome measures were the Timed 25-Foot ( T25-FW ) Walk portion of the Multiple Sclerosis Functional Composite ( MSFC ) and the five trials ( Floor , Carpet , Up and Go , Obstacles , Stairs ) of the Modified Emory Functional Ambulation Profile ( mEFAP ) . Results : The mean timed differences on the T25-FW and the five components of the mEFAP between the AFO vs. no device trials were not statistically significant . Conclusions : In MS subjects with dorsiflexion and eversion weakness , no statistically significant improvement was found performing timed tasks of functional ambulation with an AFO OBJECTIVES The objective of the study was to develop and vali date an adequate tool to evaluate the risk of bias of r and omized controlled trials , observational studies , and systematic review s assessing drug adverse events . STUDY DESIGN AND SETTING We developed a structured risk of bias checklist applicable to r and omized trials , cohort , case-control and nested case-control studies , and systematic review s focusing on drug safety . Face and content validity was judged by three experienced review ers . Interrater and intrarater reliability were determined using 20 r and omly selected studies , assessed by three other independent review ers including one performing a 3-week retest . RESULTS The developed checklist examines eight domains : study design and objectives , selection bias , attrition , adverse events information bias , other information bias , statistical methods to control confounding , other statistical methods , and conflicts of interest . The total number of questions varied from 10 to 32 depending on the study design . Interrater and intrarater agreements were fair with Kendall 's W of 0.70 and 0.74 , respectively . Median time to complete the checklist was 8.5 minutes . CONCLUSION The developed checklist showed face and content validity and acceptable reliability to assess the risk of bias for studies analyzing drug adverse events . Hence , it might be considered as a novel useful tool for systematic review s and meta-analyses focusing on drug safety 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 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 AIMS The aim of the study was to further vali date three patient-based outcome measures ( PBOM ) used to assess the outcome of surgery for stress urinary incontinence and to compare their psychometric properties with a view to determining the most appropriate measure for clinical use . METHODS The work was embedded within a r and omized controlled trial of laparoscopic and open colposuspension . The trial recruited 291 women from six centers . The three instruments compared were Bristol  Female Lower Urinary Tract Symptom Question naire ( BFLUTS )  ,  Kings Health Question naire ( KHQ )  , and the Symptom Severity Index and Symptom Impact Index ( SSI/SII ) . The International Consultation on Incontinence ( ICI ) ABC grading system of psychometric propertie 's reliability , validity , and responsiveness was used to evaluate the instruments . RESULTS From the analysis of the psychometric properties of the three instruments , the SSI/SII appeared to have the best psychometric profile ; Grade A , BFLUTS was of grade A , and KHQ was of grade B. SSI/SII had a good degree of internal consistency ( Cronbach 's alpha 0.74 - 0.78 ) . BFLUTS and KHQ both had domains in which the internal consistency was < 0.7 . The  SSI domain of the SSI/SII was the only domain to correlate to the 1-hr pad test . All domains of the SSI/SII were able to distinguish those cured from not cured and it was most responsive to change . Unlike the KHQ , the SSI/SII had no significant ceiling or floor effects . CONCLUSIONS This study has demonstrated that when instruments are used in different population s their psychometric properties may change . All three instruments analyzed had limitations when used as an outcome measure for surgery for stress urinary incontinence OBJECTIVE The purpose of this study was to develop a practical and scientifically rigorous , patient-reported outcome measure to evaluate quality of life and symptoms across the range of conditions ( eg , telangiectasias , varicose veins , edema , skin changes , leg ulcers ) in chronic venous disorders of the leg ( CVDL ) . METHODS This study was a psychometric study within the VEnous INsufficiency Epidemiological and Economic Study ( VEINES ) , an international , prospect i ve cohort study to evaluate clinical outcomes , quality of life , costs , and use of health services in CVDL . The study was set in the 166 general practice s and 116 specialist clinics in Belgium , France , Italy , and Canada ( Quebec ) that participated in the VEINES study plus in additional specialist clinics in Ottawa and Montreal . Field testing was carried out in three sample s of patients in four countries ( Belgium , France , Italy , Canada ) , including participants in the VEINES study ( n dagger 1531 ) and patients recruited in additional sample s of 88 English-speaking patients ( Canada ) and 53 French-speaking patients ( Belgium , France ) . The reliability and validity sample ( n = 615 ) included 527 VEINES patients and 88 patients from the supplementary English-speaking sample . The test-retest sample ( n = 135 ) included 53 French-speaking and 82 English-speaking patients from the supplementary sample s. The responsiveness sample included 1516 VEINES patients . The 26-item VEINES-QOL/Sym is a new , patient-reported question naire to evaluate symptoms and quality of life and is available in four language versions ( English , French , Italian , French Canadian ) . RESULTS St and ard psychometric tests confirmed the acceptability ( missing data , item endorsement frequencies , floor and ceiling effects ) , reliability ( internal consistency , item-total , inter-item correlations ) and validity ( content , construct , convergent , discriminant , known groups ) of the four language versions of the VEINES-QOL/Sym and the test-retest reliability of the English and French versions and provided preliminary evidence of responsiveness in a pooled language sample . CONCLUSION The VEINES-QOL/Sym is a practical and scientifically sound , patient-reported measure of outcomes in CVDL that has been developed with rigorous methods . As the only fully vali date d measure of quality of life and symptoms that is appropriate for use across the full spectrum of CVDL-related conditions , that is quick and easy to administer , and that is available in four language s , the VEINES-QOL/Sym provides a rigorous tool for improving the evaluation of outcomes in clinical trials , epidemiologic studies , and audit CONTEXT Most patient-reported outcome measurement tools in multiple sclerosis ( MS ) are geared toward less severely affected patients . Palliative care outcome measures have not been vali date d in patients with MS . OBJECTIVES To assess the psychometric properties of the  Core-Palliative Care Outcome Scale ( Core-POS ) and POS-MS-Symptoms ( POS-MS-S ) in patients severely affected by MS . METHODS Secondary analyses were conducted on data from a Phase II trial of palliative care in MS . Patients completed assessment s using the following five scales : Core-POS , POS-MS-S , the Multiple Sclerosis Impact Scale , the United Kingdom Neurological Disability Scale , and the Exp and ed Disability Status Scale . Data quality , scaling assumptions , acceptability , internal consistency , and construct validity of the Core-POS and POS-MS-S were determined using st and ard psychometric methods . RESULTS The 46 participants had a mean ±SD age of 52.8 ±10.6 years . The mean Exp and ed Disability Status Scale score was 7.9 ± 1.2 . Missing data were low ( 0 and 0.2 % for the Core-POS and POS-MS-S , respectively ) , and floor and ceiling effects were absent . Internal consistency was good ( Cronbach 's alpha for the Core-POS and POS-MS-S were 0.72 [ 95 % CI 0.56 - 0.84 ] and 0.81 [ 95 % CI 0.72 - 0.89 ] , respectively ) . Construct validity was consistent with a priori hypotheses 17 of 20 times . CONCLUSION Psychometric analyses confirm that the Core-POS and POS-MS-S are acceptable , reliable , and valid in patients severely affected by MS Prediction models in health care aim to predict for an individual whether a particular outcome , such as disease , is present ( diagnostic models ) or whether it will occur in the future ( prognostic models ) ( 16 ) . Diagnostic models can be used to refer patients for further testing , to initiate treatment , or to inform patients . Prognostic models can be used to aid decisions about preventive lifestyle changes , therapeutic interventions , or monitoring strategies or to stratify risk in r and omized trial design and analysis ( 7 , 8) . Potential users of prediction models include health care professionals , policymakers , guideline developers , patients , and the general public . The medical literature contains thous and s of studies developing and validating prediction models and often has numerous prediction models for the same target population and outcomes . For example , more than 60 models address breast cancer prognosis ( 9 ) , more than 250 exist in obstetrics ( 10 ) , and nearly 800 predict outcomes in patients with cardiovascular disease ( 11 ) . This proliferation of prediction models will increase further with the growth of personalized or precision medicine . Systematic review s are considered the most reliable form of evidence when addressing r and omized therapeutic studies and studies of diagnostic test accuracy ( 12 ) . In the era of personalized and precision medicine , interest in systematic review s of prediction model studies is rapidly growing , as exemplified by the formation of the Cochrane Prognosis Methods Group to support systematic review s of prognosis , including prediction model studies ( 13 , 14 ) . Guidance to facilitate systematic review s of prediction models has been developed ( Table 1 ) , including for search strategies ( 15 , 4143 ) , formulation of the review question ( 16 , 17 ) , data extraction ( 16 ) , and meta- analysis ( 17 , 2225 , 40 , 44 , 45 ) . Table 1 . Guidance on Conducting Systematic Review s of Prediction Model Studies  Assessment of risk of bias ( ROB ) is an essential step in any systematic review . Shortcomings in study design , conduct , and analysis can result in study estimates being at ROBthat is , at risk of results being flawed or distorted . When interpreting results from a systematic review , readers can draw stronger conclusions from a review based on primary studies at low ROB than from one based on studies at high or unclear ROB ( 46 ) . Identifying the studies most relevant to the setting s and population s targeted in the review ( based on the applicability of primary studies to the review question ) is also important . We therefore developed PROBAST ( Prediction model Risk Of Bias ASsessment Tool ) to address the lack of suitable tools design ed specifically to assess ROB and applicability of primary prediction model studies . PROBAST consists of 4 domains containing 20 signaling questions to facilitate ROB assessment ( 39 ) . The structure and rating system are similar to those in tools design ed to assess ROB in r and omized trials ( revised Cochrane ROB Tool [ ROB 2.0 ] ) , diagnostic accuracy studies ( QUADAS-2 [ Quality Assessment of Diagnostic Accuracy Studies 2 ] ) , and systematic review s ( ROBIS ) ( 37 , 47 , 48 ) . Although PROBAST was design ed for use in systematic review s of prediction model studies , it can also be used as a general tool for critical appraisal of ( primary ) prediction model studies . Here , we describe the rationale behind the domains and signaling questions , how to use them , and how to reach domain-level and overall judgments about ROB and applicability of primary studies to a review question . At the Web site ( www.probast.org ) , 5 filled-in examples from across the medical field illustrate these processes . Because this is an area of active research , the tool , examples , and accompanying guidance will be up date d when needed , and the latest version of PROBAST should always be downloaded from the Web site . Focus of PROBAST PROBAST is design ed to assess primary studies that develop , vali date , or up date ( for example , extend ) multivariable prediction models for diagnosis or prognosis ( Boxes 1 and 2 ) . A multivariable prediction model is defined as any combination or equation of 2 or more predictors ( such as age , sex , symptoms , signs , disease stage , or biomarkers ) for estimating for an individual the probability or risk of having ( diagnosis ) or developing ( prognosis ) a particular outcome ( 1 , 4 , 68 , 49 , 50 ) . Other names for prediction model include risk prediction model , predictive model , prediction index or rule , and risk score ( 1 , 38 , 4951 ) . Box 1 . Types of diagnostic and prognostic modeling studies or reports addressed by PROBAST . Adopted from the TRIPOD ( Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis ) and CHARMS ( CHecklist for critical Appraisal and data extraction for systematic Review s of prediction Modelling Studies ) guidance ( 8 , 16 ) . Box 2 . Differences between diagnostic and prognostic prediction model studies . PROBAST = Prediction model Risk Of Bias ASsessment Tool . Diagnostic and Prognostic Models Diagnostic prediction models estimate the probability that a certain outcome , the target condition , is currently present . Diagnostic prediction model studies typically include individuals who are suspectedbut not yet knownto have the target condition . Prognostic prediction models estimate the probability that a future outcome or event will occur , such as death , disease recurrence , disease complication , or therapy response . The time period of prediction can vary from hours ( for example , preoperatively predicting postoperative nausea and vomiting ) to years ( for example , predicting lifelong risk for a coronary event ) . Although many prognostic models enroll patients with an established diagnosis , this does not have to be the starting point , as seen in models for predicting development of diabetes in pregnant women ( 52 ) or of osteoporotic fractures in the general population ( 53 ) . Consistent with the TRIPOD ( Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis ) statement ( 7 , 8) , PROBAST thus broadly defines prognostic models as those predicting a future outcome in persons at risk for that outcome . Diagnostic and prognostic model studies often use different terms for predictors and outcomes ( Box 2 ) . The cancer literature frequently distinguishes between prognostic and predictive models , such that predictive models identify individuals with differential treatment effects ( 54 ) . These types of ( predictive ) models are outside the scope of this article . Types of Predictors , Outcomes , and Modeling Techniques PROBAST can be used to assess any type of diagnostic or prognostic prediction model aim ed at individualized predictions regardless of the predictors used ; outcomes being predicted ; or methods used to develop , vali date , or up date ( for example , extend ) the model . Predictors range from demographic characteristics , medical history , and physical examination results ; to imaging results , electrophysiology , blood , urine , or tissue measurements , and disease stages or characteristics ; to results from omics and other new biological measurements . Predictors are also called covariates , risk indicators , prognostic factors , determinants , index test results , or independent variables ( 4 , 68 , 49 , 50 , 55 , 56 , 57 ) . PROBAST distinguishes between c and i date predictors and predictors included in the final model ( 57 ) . C and i date predictors are variables considered potentially predictive of the outcome presence ( diagnosis ) or occurrence (prognosis)that is , all those evaluated in the study regardless of whether they are included in the final multivariable model . PROBAST primarily addresses prediction models for binary and time-to-event outcomes because these are the most common in medicine . However , the tool can also be used to assess models predicting nonbinary outcomes , such as continuous scores ( for example , pain scores or cholesterol levels ) or categorical outcomes ( for example , the Glasgow Coma Scale ) . Almost all PROBAST signaling questions apply equally to continuous and categorical outcomes , except questions addressing number of outcome events per predictor and certain measures of model performance ( such as the c-statistic ) , which are not relevant to continuous outcomes . Prediction models usually involve regression modeling techniques , such as logistic regression or survival models . Prediction models may also be developed or vali date d using nonregression techniques , such as neural networks , r and om forests , or support vector machines . As the use of routine care ( and big ) data increases , additional modeling techniques are becoming more common , including machine and artificial learning models . The main differences between studies using regression and other types of prediction modeling include the methods of data analysis ; nonregression development models can often have greater risks of overfitting when data are sparse , and the potential lack of transparency can affect the applicability and usability of the models . In the section on tailoring PROBAST with additional signaling questions , we provide guidance about how PROBAST can be adapted to address other types of outcomes and modeling techniques . Types of Review Questions PROBAST can be used to assess different types of systematic review questions . For some review questions , all prediction model studies are relevant ( including both development and validation ) , but for other questions only validation studies are relevant . Box 3 gives examples of potential review questions for both prognostic and diagnostic prediction models where PROBAST is applicable . CHARMS ( CHecklist for critical Appraisal and data extraction for systematic Review s of prediction Modelling Studies ) and Table 2 provide explicit guidance on how to frame a focused question for review s of prediction model studies ( 16 , 17 ) . Box 3 . Examples of systematic review questions for which PROBAST is suitable . There are various different questions that systematic review s
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 .