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 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. How do doctors refer to patient-reported outcome measures (PROMS) in oncology consultations? Qualitative analysis of patients’ feedback from a PROMs survey of cancer patients in England Clinical predictors of foot orthoses efficacy in individuals with patellofemoral pain. Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol Premature rupture of the membranes: effect of penicillin prophylaxis and long-term outcome of the children. The Responsiveness and Minimal Important Change of the Western Ontario Shoulder Instability Index and Oxford Shoulder Instability Score Oral misoprostol for induction of labor in prelabor rupture of membranes (PROM) at term: a randomized control trial Assessing the performance of the EQ-VAS in the NHS PROMs programme INFANT GROWTH AND HUMAN MILK REQUIREMENTS: A Fresh Approach Effect of superficial heat, deep heat, and active exercise warm-up on the extensibility of the plantar flexors. Reliability and Validity of 6 Measures of Pain, Function, and Disability for Ankle Arthroplasty and Arthrodesis Improving the reliability of event-based laboratory tests of prospective memory Does acupuncture used in nulliparous women reduce time from prelabour rupture of membranes at term to active phase of labour? A randomised controlled trial. Reliability and validity of the Foot and Ankle Outcome Score: a validation study from Iran Comparison of the effects of exercise in water and on land on the rehabilitation of patients with intra-articular anterior cruciate ligament reconstructions. Validation of the Turkish version of the foot and ankle outcome score Psychometric Comparison of the PROMIS Physical Function CAT With the FAAM and FFI for Measuring Patient-Reported Outcomes Criteria for Success after Surgery for Cervical Radiculopathy; Estimates for a Substantial Amount of Improvement in Core Outcome Measures. Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis. 17-Hydroxyprogesterone caproate to prolong pregnancy after preterm rupture of the membranes: early termination of a double-blind, randomized clinical trial
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 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 Purpose We conducted a secondary qualitative analysis of consultations between oncologists and their patients to explore how  patient-reported outcome measures ( PROMs ) data were referred to in the process of ( 1 ) eliciting and exploring patients ’ concerns ; ( 2 ) making decisions about supportive treatment and ( 3 ) making decisions about chemotherapy and other systemic treatments . Methods We purposively sample d audio recordings of 18 consultations from the intervention arm and 4 from the attention control arm of a previous UK r and omised controlled trial of the feedback of PROMs data to doctors ( Velikova et al. in J Clin Oncol 22(4):714–724 [ 1 ] ) . We used a combination of content and conversation analysis to examine how opportunities for discussion of health-related quality of life issues are opened up or closed down within the consultation and explore why this may or may not lead to changes in patient management . Findings Explicit reference to the PROMs data provided an opportunity for the patient to clarify and further elaborate on the side effects of chemotherapy . High scores on the PROMs data were not explored further if the patient indicated they were not a problem or were not related to the cancer or chemotherapy . Symptomatic treatment was more often offered for problems like nausea , constipation , pain and depression but much less so for fatigue . Doctors discussed fatigue by providing a cause for the fatigue ( e.g. the chemotherapy ) , presenting this as ‘ something to be expected ’ , minimising its impact or moving on to another topic . Chemotherapy regimens were not changed on the basis of the PROMs data alone , but PROMs data were sometimes used to legitimise changes . Conclusions Explicit mention of PROMs data in the consultation may strengthen opportunities for patients to elaborate on their problems , but doctors may not always know how to do this . Our findings have informed the development of a training package to enable doctors to optimise their use of PROMs data within the consultation Objective This study examined how free-text comments from cancer survivors  could complement formal patient-reported outcome measures ( PROMs ) , as part of the Engl and PROMs survey programme for cancer . Design A qualitative content analysis was conducted of responses to a single open-ended free-text question placed at the end of the cross-sectional population -based postal question naire . Setting Individuals were identified through three UK Cancer Registries and question naires were posted to their home addresses . Participants A r and om sample of individuals ( n=4992 ) diagnosed with breast , colorectal , non-Hodgkins lymphoma or prostate cancer at 1 , 2 , 3 and 5 years earlier . Results 3300 participants completed the survey ( 68 % response rate ) . Of these 1056 ( 32 % ) completed the free-text comments box , indicating a high level of commitment to provide written feedback on patient experience . Almost a fifth ( 19 % ) related experiences of excellent care during the treatment phase , with only 8 % reporting negative experiences . This contrasted with experiences of care after primary cancer treatment where the majority were negative . Factors impacting negatively upon patient-reported outcomes included the emotional impact of cancer ; poor experiences of treatment and care ; comorbidities , treatment side effects , social difficulties and inadequate preparation for a wide range of sometimes long-lasting on-going physical and psychological problems . Mediating factors assisting recovery incorporated both professional-led factors , such as quality of preparation for anticipated problems and aftercare services , and participant-led factors , such as learning from other cancer survivors and self-learning through trial and error . The support of friends and family was also a factor in participants ' outcomes . Conclusions This analysis of free-text comments complements quantitative analysis of PROMs measure 's by illuminating relationships between factors that impact on quality of life ( QoL ) and indicate why cancer patients may experience significantly worse QoL than the general population . The data suggest more systematic preparation and aftercare for individuals to self-manage post-treatment problems might improve QoL outcomes among cancer survivors PURPOSE There is emerging evidence that foot orthoses are effective in the management of  patellofemoral pain syndrome ( PFPS ) . However , the identification of those most likely to benefit from foot orthoses has not been adequately explored . The aim of this study was to develop a preliminary clinical prediction rule to help identify individuals with PFPS who are most likely to benefit from foot orthoses . METHODS A total of 60 individuals with PFPS were issued with noncustomized prefabricated foot orthoses containing built-in arch supports and 4 ° rear foot varus wedging . Patient-reported level of improvement was documented at 12 wk . Potential baseline predictor variables of interest included patient demographics , pain characteristics , footwear motion control properties , foot and ankle characteristics , and functional performance measures . RESULTS Fourteen ( 25 % ) participants reported marked improvement at 12 wk . The number of participants with marked improvement increased to 78 % if three of the following four criteria were met : footwear motion control properties score of < 5.0 ( indicative of less supportive footwear ) , usual pain < 22.0 mm , ankle dorsiflexion range of motion ( knee flexed ) < 41 ° , and reduced single-leg squat pain when wearing the orthoses . CONCLUSIONS Individuals with PFPS who wear less supportive footwear , report lower levels of pain , exhibit less ankle dorsiflexion range of motion , and report an immediate reduction in pain with foot orthoses when performing a single-leg squat are more likely to benefit from foot orthoses Background UK-wide national clinical guidelines promote routine 6-month post-stroke follow-up assessment . However , as part of this 6-month assessment little information is gathered from the patient ’s perspective . The means of collecting this patient-centred information might be served best by a patient-reported outcome measure ( PROM ) at the 6-month assessment time point . Currently , four different methods of 6-month follow-up assessment occur ; the most common being face-to-face interview followed by telephone interview , postal question naire and online question naire . Therefore , this study will investigate if the acceptability of telephone , online or postal administration of a PROM at the 6-month post-stoke time point is not inferior to face-to-face administration . Methods / design A UK multicentre , blinded ( analyst and research er ) , pragmatic , non-inferiority study , with 80 % power using a 2.5 % non-inferiority margin was design ed to compare the acceptability of three modes of administration ( telephone interview , postal question naire and online question naire ) compared with face-to-face interview administration of a PROM . We plan to approach and r and omise a minimum of 808 potentially eligible participants , 202 participants per group . Discussion The aim of this ongoing research is to underst and if there is a difference between face-to-face administration and the other three methods of administering a PROM as a patient-centred supplement to the 6-month review for stroke survivors . In utilising a pragmatic design , it is believed that this study will offer UK wide generalisable results , of the acceptability of the methods under investigation , to inform clinicians and commissioners of stroke services . Trials registration Clinical Trials.gov : NCT03177161 . Registered on 6 June 2017 To assess the value of prophylaxis with penicillin in women with premature rupture of membranes ( PROM ) and the  long-term outcome of children born after prolonged PROM , we studied 221 women with this condition .  Penicillin ( 5 mu twice , 6 hours apart ) was given intravenously to 50 women and placebo to 51 women , whereas 76 comparable patients were treated without penicillin or placebo . The time interval between PROM and delivery ranged from 14 hours to 56 days . Chorioamnionitis occurred more frequently ( p less than 0.05 ) among patients with placebo ( 14 % ) than among those treated with penicillin ( 2 % ) . One puerperal endometritis appeared in the placebo group compared with none in the penicillin group . One newborn ( 1.7 % ) born to a mother with placebo prophylaxis developed septicemia , compared with none in the penicillin group . The outcomes of pregnancies complicated with PROM treated without penicillin or placebo were comparable with those in the placebo group . In addition , we compared somatic and psychomotor development of 159 children born to mothers with prolonged PROM ( more than 12 hours ; mean , 5.6 days ; range , 14 to 1344 hours ) with those of 43 children born at similar gestational age within 5 hours after PROM . No pulmonary sequelae could be linked to the long time period between PROM and delivery , but infants born soon after PROM more often ( p less than 0.05 ) had cerebral palsy ( 8 of 43 , 18.6 % ) than did infants born after prolonged PROM ( 7 of 159 ; 4.4 % ) . We conclude that , in cases with PROM , penicillin prophylaxis decreases maternal and neonatal infectious morbidity and that the long interval between PROM and delivery does not impair the long-term outcome for these children • STUDY DESIGN : Prospect i ve cohort study . • BACKGROUND : Patient‐reported outcome measurements ( PROMs ) are widely used to evaluate functional limitations . Considering PROMs for shoulder instability , information is lacking with regard to what constitutes a relevant change from baseline scores . • OBJECTIVES : To evaluate the responsiveness of the Western Ontario Shoulder Instability Index ( WOSI ) and the  Oxford Shoulder Instability Score ( OSIS ) and estimate their minimal important change ( MIC ) . • METHODS : One hundred five consecutive patients with shoulder instability completed 5 PROMs at baseline and at 6‐month follow‐up . The PROMs included the  WOSI and OSIS , the Simple Shoulder Test , the Oxford Shoulder Score , and the Disabilities of the Arm , Shoulder and H and assessment .  Patients also rated their functional change on an anchor question at follow‐up . Responsiveness was evaluated by testing 9 hypotheses regarding predefined correlations between the changes in PROM scores , by calculating the area under the receiver operating characteristic curve and by calculating the st and ardized response mean and effect size statistics . The MIC was determined by identifying the optimal cutoff on the receiver operating characteristic curve . • RESULTS : Seven out of 9 hypotheses ( 78 % ) were confirmed ; as expected , a high correlation ( 0.77 ) was found between change scores of the WOSI and OSIS , whereas the correlations of the change scores of the WOSI and OSIS with those of general shoulder PROMs were slightly lower ( 0.61‐0.75 ) . The area under the curve was 0.83 ( 95 % confidence interval : 0.75 , 0.91 ) for the OSIS and 0.82 ( 95 % confidence interval : 0.74 , 0.90 ) for the WOSI . The MIC was about 6 points for the OSIS and about 14 points for the WOSI . • CONCLUSION : Both the WOSI and OSIS are able to measure change in shoulder function in patients with shoulder instability . The estimated MIC is 6 points for the OSIS ( on a scale from 0 to 48 ) and 14 points for the WOSI ( on a scale from 0 to 100 ) . •KEY WORDS : clinimetrics , functional outcome measures , outcome assessment , Objective . To compare the efficacy of two different dosages of oral misoprostol ( 50 and 100 μg ) with control , in medical induction of labor for patients with prelabor rupture of membranes ( PROM ) at term . Methods . One hundred women with PROM at term were r and omized to receive placebo ( vitamin B6 50 mg , control ) , 50 μg ( treatment group 1 ) , or 100 μg ( treatment group 2 ) of oral misoprostol every 4 h to a maximum of six doses . The main outcome measures included time interval from onset of PROM to delivery , duration of first stage of labor , and occurrence of vaginal delivery within 24 h from PROM . Results . The time intervals from PROM to delivery were significantly reduced in both treatment groups compared to control ( control , 25.1±10.5 h ; treatment group 1 , 14.5±6.2 h ; and treatment group 2 , 13.0±6.1 h , p<0.0001 for both ) . The duration of the first stage of labor was significantly shortened only in treatment group 2 compared to control ( 3.3±2.5 versus 6.2±3.4 h , p=0.01 ) . Of those who delivered vaginally ( 93 % in treatment group 1 and 97 % in treatment group 2 ) , significantly more women delivered within 24 h of PROM in the treatment group compared to the control group ( 50 % , p<0.05 ) . Conclusions . Oral misoprostol 50 μg every 4 h is safe , cheap , and as effective as 100 μg in reducing the PROM to delivery time interval and labor duration in primiparous women . The same effect is not observed in a multiparous group Objectives The study aims to increase knowledge about the performance of the EuroQol-visual analogue scales ( EQ-VAS ) in the UK NHS patient-reported outcome measures ( PROMs ) programme , which covers groin hernia , hip and knee replacement and varicose vein surgery , and make suggestions for improved collection , coding and analysis of data . Methods Four hundred scanned images of matched before- and -after EQ-VAS PROMs responses were selected at r and om . These were classified according to the different ways in which they were completed . Patient-level PROMs programme data linked to Hospital Episode Statistics for all patients from April 2009 to February 2011 were used to analyse the relationship between the EQ-VAS and the EQ-5D profile , index-weighted profile and condition-specific instruments . The linked PROMs and HES data comprise 331,951 anonymised patient records . Results A large majority ( 95 % ) of EQ-VAS responses were completed in an unambiguous way , but only a minority ( 45 % ) conformed strictly to the instructions given , posing challenges for data coding . The EQ-VAS data have a predictable and consistent relationship with the EQ-5D profile , although the correlations between the EQ-VAS and other measures of patient-reported health , both before and after surgery and in the change between them , are weak . Conclusions EQ-VAS data might be improved by providing better guidance on collection and coding . It is argued that the observed differences in results from EQ-VAS and other measures of health reflect the fact that it measures a broader underlying construct of health , arguably providing a means of summarising overall health that is closer to the patient ’s perspective Abstract The relationship between growth and the breast-milk plus complementary food intake of a group of British babies has been studied prospect ively up to 8 months . From the data the human milk needs of  solely breast-fed children to grow along the 5th , 50th , and 95th Gentile of the NCHS st and ard have been predicted using multiple regression analysis . The values obtained are substantially lower than previous estimates and they may form a more practical guideline for the evaluation of lactational adequacy within a community . Individual variation is important . It is futile to identify a single age when breast-feeding becomes inadequate as the sole source of food BACKGROUND AND PURPOSE Warm-up prior to static stretching enhances muscle extensibility . The relative effectiveness of different modes of warm-up , however , is unknown . The purpose of this study was to evaluate the effectiveness of superficial heat , deep heat , and active exercise warm-up prior to stretching compared with stretching alone on the extensibility of the plantar-flexor muscles . SUBJECTS Ninety-seven subjects ( 59 women , 38 men ) with limited dorsiflexion range of motion ( ROM ) were r and omly assigned to 1 of 5 groups . Female subjects had a mean age of 27.6 years ( SD=7.68 , range=17 - 50 ) , and male subjects had a mean age of 26.8 years ( SD=6.87 , range=18 - 48 ) . METHODS The first group ( group 1 ) was a control group and did not perform the stretching protocol . The 4 experimental groups ( groups 2 - 5 ) performed a stretching protocol 3 days per week for 6 weeks . Group 2 performed the static stretching protocol only ; group 3 performed active heel raises before stretching ; group 4 received 15 minutes of superficial , moist heat to the plantar-flexor muscles before stretching ; and group 5 received continuous ultrasound for 7 minutes before stretching .  Dorsiflexion ROM measurements were taken initially and after 2 , 4 , and 6 weeks . RESULTS All experimental groups increased active and passive range of motion ( AROM and PROM ) . The mean AROM/PROM differences at 6 weeks were 1.11/1.39 degrees for group 1 , 4.10/6.11 degrees for group 2 , 4.16/4.21 degrees for group 3 , 4.38/4.90 degrees for group 4 , and 6.20/7.35 degrees for group 5 . The group receiving ultrasound before performing the stretching protocol ( group 5 ) displayed the greatest increase in both AROM ( 6.20 ( ) and PROM ( 7.35 ( ) . DISCUSSION AND CONCLUSION Among the modalities tested , the use of ultrasound for 7 minutes prior to stretching may be the most effective for increasing ankle dorsiflexion ROM Background : Patient-reported outcome measures are increasingly used evaluating clinical care . Many measures used to assess operative hindfoot interventions vary in content , and some have not been psychometrically vali date d in this population . The purpose of this study was to compare measurement properties of  6 lower-extremity patient-reported outcome measures  , and to evaluate their reliability and validity in light of patients ’ preferences . Methods : Cross-sectional survey of 42 preoperative and 100 postoperative patients completed 6 lower-extremity outcome measures  on 2 occasions : Foot Function Index ( FFI ) , Ankle Osteoarthritis Scale ( AOS ) , patient-reported items of the  American  Orthopaedic Foot & Ankle Society Question naire ( AOFAS ) , Lower Extremity Functional Scale ( LEFS ) , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , and the Short Musculoskeletal Function Assessment ( SMFA ) , as well as measures of preference , and symptoms . Results : Internal consistency was good to excellent for all scales and subscales ( α = .84-.97 ; ICC [ 2,1 ] = .81-.96 ) . Correlations between scales ranged from .50 ( WOMACStiffness and FFIActivity Limitations ) to .92 ( LEFS and SMFAOverall , WOMACPain and AOSOverall , FFIOverall and AOFASOverall ) . Higher correlations occurred within instruments ( r = .97 AOSPain and AOSOverall ) and between similar subscales from different instruments ( r = .91 WOMACPain and AOSPain ) . Construct validity showed moderate to high correlations to global ratings of Pain , Stiffness , and difficulty performing Daily Activities . The highest correlations ( r > .75 ) occurred between Pain and AOSOverall ( r = .84 ) , stiffness and WOMACStiffness ( r = .81 ) , and Daily Activities and AOSDisability ( r = .87 ) . Patients rated instruments by preference . FFI , WOMAC , LEFS , and SMFA rated favorably for length . FFI , WOMAC , LEFS , and AOFAS rated high for underst and ability . FFI was rated by postoperative patients as most likely to capture change due to surgery . SMFA rated the best overall . Conclusions : Direct comparison of instruments revealed similarity between scales in construct validity and reliability . Patient preferences supported the use of these scales . Foot-specific instruments offered no clear advantage over lower-extremity instruments . Level of Evidence : Level II , prospect i ve comparative study Laboratory tests of event-based prospect i ve memory ( ProM ) require participants to perform actions in response to infrequent cues in a background task . We conducted three experiments to assess and improve the reliability of this popular procedure . In Experiment 1 , we tested college students on 2 separate days and found that the alternate-forms reliability of ProM accuracy was quite low ( r = .31 ) , although general knowledge accuracy was more reliable ( r= .89 ) . In Experiment 2 , a statistically significant difference in reliability emerged between conditions with a low ( n = 6 ) versus a high ( n = 30 ) number of ProM targets . Finally , lower ProM accuracy increased reliability in Experiment 3 . Adopting these straightforward changes may enhance the search for individual differences in BACKGROUND To assess if acupuncture influences the onset of labour and the need for induction after prelabour rupture of membranes ( PROM ) in nulliparous women . Further , to investigate a possible effect of acupuncture on the woman 's wellbeing . METHODS In a r and omised controlled trial ( RCT ) , 106 nulliparous women with PROM were allocated to an acupuncture group ( AG ) or a control group ( CG ) . The outcome measures were time from PROM to onset of active phase of labour , and rate of inductions if labour was absent after 2 days . The women 's self-reported wellbeing was registered on a Visual Analogue Scale ( VAS ) . RESULTS There was no statistically significant difference between the 2 groups regarding time from PROM to active phase ( median times in AG versus CG : 15 versus 20.5 h , p=0.34 ) . Additionally , there was no difference between the 2 groups in the need for induction . We found no significant differences in self-reported wellbeing , but the women receiving acupuncture considered their treatment to be more positive than the controls ( p=0.003 ) . No adverse effects were reported . CONCLUSIONS Acupuncture treatment used in nulliparas after PROM showed no significant effect in reducing time to active labour or in reducing rate of inductions . There was no change in wellbeing as a result of acupuncture , but it was considered positive to receive this kind of treatment while waiting for labour to begin 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 BACKGROUND AND PURPOSE Exercises in water have been shown to be effective for improving strength and passive range of motion ( PROM ) . Traditional rehabilitation following intra-articular anterior cruciate ligament ( ACL ) reconstruction has taken place on l and . This study was design ed to compare the effects of exercises in water on strength and girth of the thigh musculature , knee PROM , joint laxity , effusion , and functional outcome with the effects of similar exercises on l and in subjects following intra-articular reconstruction of the ACL . SUBJECTS Twenty subjects were r and omly assigned to either a group that exercised on l and or a group that exercised in water . METHODS Thigh girth , joint effusion , and knee PROM measurements were recorded at 2-week intervals for the first 8 weeks postoperatively . Isokinetic and isometric peak torque measurements for the thigh musculature , knee joint laxity assessment s , and Lysholm scores were obtained at the end of 8 weeks . RESULTS Higher outcome scores were recorded in the water group than in the l and group , as measured by Lysholm scales . No differences were noted between groups for knee PROM , thigh girth , or quadriceps femoris muscle performance . In the water group , less joint effusion was noted after the 8 weeks . In the l and group , greater peak torque for isokinetic knee flexion was recorded . CONCLUSION AND DISCUSSION Although exercise in water may not be as effective as exercise on l and for regaining maximum muscle performance , rehabilitation in water may minimize the amount of joint effusion and lead to greater self-reports of functional improvement in subjects with intra-articular ACL reconstructions The objective is to develop a Turkish version of the foot and ankle outcome score ( FAOS ) and to investigate its validity and reliability . The Turkish version of FAOS was developed after the translation and back-translation . The translated version was pretested on 20 patients with rheumatoid arthritis . Then , the Turkish FAOS was administered to 55 patients having foot and ankle problems . They were also evaluated by using the four subscales of the Turkish version of AIMS 2 , and the Turkish version of SF-36 question naire to test validity . Fifty patients filled out the FAOS for second time to determine test – retest reliability . Construct validity was investigated with use of Spearman ’s rank correlation coefficient . Test – retest reliability was assessed with use of the intraclass correlation coefficient ( ICC ) and Cronbach ’s alpha score . The psychometric properties of the Turkish FAOS were generally similar to the original FAOS . The r and om ICC for the five subscales ranged from 0.70 to 0.96 . The Cronbach ’s alpha coefficient ranged from 0.79 to 0.97 . Construct validity of the FAOS was good . The Turkish FAOS correlated with the SF-36 and AIMS 2 scales . The Turkish version of FAOS was valid and reliable instrument to assess the foot and ankle related problems . However , to assess its responsiveness further studies are needed Background : Selecting optimal patient-reported outcome ( PRO ) instruments is critical to improving the quality of health care . The purpose of this study was to compare the reliability , responsiveness , and efficiency of three PRO measures : the Foot and Ankle Ability Measure – Activity of Daily Living subscale ( FAAM_ADL ) , the Foot Function Index 5-point verbal rating scale ( FFI-5pt ) , and the PROMIS Physical Function computerized adaptive test ( PF CAT ) . Methods : Data were aggregated from 10 clinical sites in the AOFAS ’s National Orthopaedic Foot and Ankle Research ( OFAR ) Network from 311 patients who underwent elective surgery for a disorder of the foot or ankle . Patients were administered the FAAM_ADL , FFI-5pt , and PF CAT at their preoperative visit and at 6 months after surgery . Reliabilities were evaluated using a Rasch model . Responsiveness was calculated using paired sample s t test and efficiency was recorded as number of seconds to complete the instrument . Results : Similar reliabilities were found for the three instruments . Item reliabilities for FAAM_ADL , FFI-5pt , and PF CAT were all .99 . Pearson reliabilities for FAAM_ADL , FFI-5pt , and PF CAT were .95 , .93 , and .96 , respectively . On average , patients completed the FAAM_ADL in 179 seconds , the FFI-5pt in 194 seconds , and the PF CAT in 44 seconds , ( P < .001 ) . The PF CAT and FAAM_ADL showed significant improvement ( P = .01 and P = .001 , respectively ) in patients ’ physical function after treatment ; the FFI-5pt did not show improvement . Conclusions : Overall , the PF CAT performed best in terms of reliability , responsiveness , and efficiency in this broad sample of foot and ankle patients . It can be a potential replacement for the conventional PRO measures , but further validation is needed in conjunction with the PROMIS Pain instruments . Level of Evidence : Level I , prospect i ve comparative outcome study IMPORTANCE Defining clinical ly meaningful success criteria from patient-reported outcome measures ( PROMs ) is crucial for clinical audits , research and decision-making . PURPOSE We aim ed to define criteria for a successful outcome 3 and 12 months after surgery for cervical degenerative radiculopathy ( CDR ) on recommended PROMs . STUDY DESIGN Prospect i ve cohort study with 12 months follow-up . PATIENT SAMPLE Patients operated at one or two levels for cervical radiculopathy included in the Norwegian Registry for Spine Surgery ( NORspine ) from 2011 to 2016 . OUTCOME MEASURES Neck Disability Index ( NDI ) , Numeric Rating Scale for neck pain ( NRS-NP ) and arm pain ( NRS-AP ) , health-related quality -of-life EuroQol 3L ( EQ-5D ) , general health status ( EQ-VAS ) . METHODS We included 2868 consecutive CDR patients operated for cervical radiculopathy in one or two levels and included in the Norwegian Registry for Spine Surgery ( NORspine ) . External criterion to determine accuracy and optimal cut-off values for success in the PROMs was the Global Perceived Effect Scale ( GPE ) . Success was defined as " much better " or " completely recovered " . Cut-off values were assessed by analyzing the area under the receiver operating curves ( ROC ) for follow-up scores , mean change scores , and percentage change scores . RESULTS All PROMs showed high accuracy in defining success and non-success and only minor differences were found between 3- and 12-month scores . At 12 months , the area under the ROC for follow-up scores were 0.86 - 0.91 , change scores were 0.74 - 0.87 , and percentage change scores were 0.74 - 0.91 . Percentage scores of NDI and NRS-AP showed the best accuracy . The optimal cut-off values for each PROM showed considerable overlap across those operated due to disc herniation and spondylotic foraminal stenosis . CONCLUSIONS All PROMs , especially NDI and NRS-AP , showed good to excellent discriminative ability in distinguishing between a successful and non-successful outcome after surgery due to cervical radiculopathy . Percentage change scores are recommended for use in research and clinical practice OBJECTIVE The purpose of this study was to determine if antioxidant supplementation during pregnancy reduces the incidence of  premature rupture of the membranes ( PROM ) .  STUDY DESIGN A placebo-controlled , double-blind trial was conducted . PROM and preterm PROM ( PPROM ) were planned secondary outcomes of the trial . Women between 12(0/7 ) and 19(6/7 ) weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were r and omized to daily treatment with both vitamin C ( 1000 mg ) and E ( 400 IU ) or placebo . RESULTS Outcome data for PROM were available for 697 of 739 patients . The rates of PROM ( 37/349 [ 10.6 % ] vs 19/348 [ 5.5 % ] ; adjusted risk ratio [ RR ] 1.89 [ 95.42 % CI , 1.11 - 3.23 ] ; P = .015 ) , and PPROM ( 16/349 [ 4.6 % ] vs 6/348 [ 1.7 % ] ; RR 2.68 [ 1.07 - 6.71 ] ; P = .025 ) were increased in the antioxidant group . CONCLUSION Contrary to expectations , vitamins C and E supplementation in this dose combination may be associated with an increased risk of PROM and PPROM Background Progestational agents may reduce the risk of preterm birth in women with various risk factors . We sought to test the hypothesis that a weekly dose of 17-hydroxyprogesterone caproate ( 17P ) given to women with preterm rupture of the membranes ( PROM ) will prolong pregnancy and thereby reduce neonatal morbidity . Methods Double-blind , placebo-controlled r and omized clinical trial . Women with PROM at 23.0 to 31.9 weeks of gestation were r and omly assigned to receive a weekly intramuscular injection of 17P ( 250 mg in 1 mL castor oil ) or placebo ( 1 mL castor oil ) . The primary outcome was the rate of continuing the pregnancy until 34.0 weeks of gestation or until documentation of fetal lung maturity at 32.0 to 33.9 weeks of gestation . Planned secondary outcomes were duration of latency period and rate of composite neonatal morbidity . Enrollment of 111 participants per group , 222 total , was planned to yield 80 % power to detect an increase in the primary outcome from 30 % with placebo to 50 % with 17P . Results Twelve women were enrolled of whom 4 were r and omly assigned to receive 17P and 8 to receive placebo . The trial was terminated prematurely because of two separate issues related to the supply of 17P . No adverse events attributable to 17P were identified . Conclusion Because of premature termination , the trial does not have adequate statistical power to evaluate efficacy or safety of 17P in women with PROM . Nonetheless , ethical principles dictate that we report the results , which may contribute to possible future metaanalyses and systematic review s . Trial Registration Clinical Trials.gov : NCT01119963Supported by a research grant from the Center for Research , Education , and Quality , Pediatrix Medical Group , Sunrise ,
More evidence was available for the measurement properties of the FAOS and the FAAM , but overall evidence supporting all measurement properties is not yet sufficient .
Purpose In the foot and ankle literature , a wide range of patient-reported outcome measures ( PROMs ) is used , however , consensus as to which PROMs are preferred is lacking .
Selection of a PROM is among other reasons , often based on measurement properties without considering the method ological quality of the studies that evaluate these measurement properties .
The aim of current study was first to identify the most frequently used foot and ankle-specific PROMs in recent orthopaedic foot and ankle literature , and second to conduct a systematic review to synthesize and critically appraise the measurement properties of these PROMS .