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Background/aimsTo compare long-term outcomes of primary versus secondary (postgraft failure) Boston keratoprosthesis type 1 (KPro) implantation.MethodsMedical records of patients at the Centre hospitalier de l’Université de Montréal having undergone KPro implantation between 2008 and 2017 were reviewed and included if they had a preoperative Snellen best-corrected visual acuity (BCVA) of 20/100 or worse and a minimum of 5 years of follow-up. Eighty-two eyes were separated into two cohorts (40 primary, 42 secondary KPro) and BCVA, complications and device retention were evaluated between groups.ResultsBCVA improved from baseline in both groups at each year; this was significant at all five postoperative years in the primary group and the first 3 years in the secondary group (pConclusionPrimary KPro yielded favourable long-term visual outcomes but had more complications and lower retention rates than secondary KPro, likely explained by preoperative indications. Primary device implantation represents a favourable option for patients for whom grafts are likely to fail.

PURPOSE To compare the sealability of femtosecond laser (FSL)-assisted corneal incisions (CIs) with that of triplanar manual (M)-CIs and to determine FSL wound parameters minimizing leakage. SETTING Private practice. DESIGN Phase IV, single-surgeon, retrospective cohort study. METHODS One eye per patient was included. Two groups defined by the main wound (FSL-CI or M-CI) were compared for leakage, inferred by placement of a suture at the end of surgery. Leakage in FSL-CIs was analyzed as a function of customizable wound parameters: anterior plane depth (APD), posterior plane depth (PPD), anterior side-cut angle (ASCA), and posterior side-cut angle (PSCA). The risk of leakage of FSL-CIs with optimal and nonoptimal parameters was further compared with that of M-CIs. RESULTS A total of 1100 eyes (757 [68.8%] FSL-CI; 343 [31.2%] M-CI) were included. Wound leakage occurred in 133 FSL-CI (17.6%) and 30 M-CI eyes (8.7%) (P < .001). FSL wound parameters associated with the lowest risk of leakage were 60% APD, 70% PPD, 120 degrees ASCA, and 70 degrees PSCA. FSL-CIs constructed with at least 3 optimal parameters (60% APD, 70% PPD, and 120 degrees ASCA) had a similar risk of leakage to M-CIs (odds ratio [OR], 1.1; 95% CI, 0.5-2.3). FSL-CIs with suboptimal parameters had twice the risk of leakage of M-CIs (OR, 2.0; 95% CI, 1.1-3.8). CONCLUSIONS Overall, FSL-CIs leaked more than M-CIs. However, FSL-CIs with optimized wound profiles had an equivalent risk of leakage to M-CIs. Wound parameter customization is an asset of FSL technology that allows optimization of FSL-CI sealability.

PURPOSE To determine patient-reported vision-related quality of life (VR-QoL) after Boston type I keratoprosthesis (BKPro) and its determinants. METHODS A cross-sectional study including consecutive consenting BKPro patients was conducted. The French National Eye Institute Visual Function Questionnaire-25 measured postoperative VR-QoL. Medical charts were retrospectively reviewed for demographics, ocular comorbidities, indication for surgery, postoperative visual acuity (VA), and complications. Univariate analyses were used to identify VR-QoL determinants. Multivariate linear regression was additionally performed for patients operated unilaterally, using VR-QoL as the dependent variable and age, sex, and postoperative VA as covariates. P < 0.05 indicated statistical significance. RESULTS Sixty-three patients, aged 63 ± 13 years, with a mean follow-up of 54 ± 19 months, were included. VR-QoL was measured 53 ± 18 months postoperatively. "Composite" VR-QoL scores in patients with unilateral (n = 51) and bilateral (n = 12) BKPro were 65 ± 23 and 63 ± 19, respectively, and did not significantly differ between the 2 groups (P = 0.71). In patients with unilateral BKPro, VR-QoL was determined by postoperative VA in the better eye, which was the contralateral nonoperated eye in most cases. Achieved vision in the operated eye contributed to VR-QoL when vision in the contralateral nonoperated eye was poorer. In the bilateral BKPro group, VR-QoL was determined by postoperative VA in the better eye and the number of ongoing complications. CONCLUSIONS Five-year VR-QoL scores were lower in BKPro patients compared with healthy cohorts reported in the literature and were similar after unilateral and bilateral BKPro surgery. The main determinant of postoperative VR-QoL was postoperative vision in the better eye.

This is a case report of post-laser in situ keratomileusis (LASIK) multidrug-resistant Mycobacterium abscessus keratitis managed with combined topical amikacin and linezolid, flap amputation, and corticosteroids. A 34-year-old woman presented with a corneal interface infiltrate 3 weeks after LASIK. Cultures isolated mycobacteria. The infiltrate did not improve under intensive topical therapy and interface irrigation with empiric antibiotics over 5 weeks, and the infiltrate progressed to severe inflammation and stromal neovascularization. After identification of M abscessus susceptible only to amikacin and linezolid, antimicrobials were adjusted and the flap was ablated. Cultures repeated 1 week later came back negative. However, stromal inflammation and neovascularization persisted. Topical steroids achieved regression of the inflammation within 1 week. Identification of the mycobacterial pathogen and its susceptibilities is essential given the possibility of multidrug resistance. Topical linezolid can be effective in susceptible species. Corticosteroids can be helpful in cases with severe inflammation.

PURPOSE To identify the incidence, risk factors, and outcomes of infectious keratitis after Boston type 1 keratoprosthesis (kpro) implantation. METHODS Retrospective case series of kpro procedures at the Stein Eye Institute and the Centre Hospitalier de l'Universite de Montreal between May 1, 2004, and December 31, 2018. Data were collected regarding ocular history, operative details, postoperative management, microbiologic profile, treatment, and outcomes. Log-rank test and Cox proportional hazard ratio (HR) were used to evaluate for an association between risk factors and outcomes. RESULTS A total of 349 kpro procedures were performed in 295 eyes of 268 patients. Fifty-seven cases of presumed infectious keratitis were identified after 53 procedures (15.2%) in 50 eyes (16.9%) of 49 patients (18.3%). The incidences of culture-positive bacterial and fungal keratitis were 0.014 and 0.004 per eye-year, respectively. Persistent corneal epithelial defect formation (P < 0.001) and cicatricial disease (HR: 1.98, 95% confidence interval, 1.02-3.83) were associated with a significantly higher incidence of infectious keratitis. For the 53 cases with a known outcome, medical therapy achieved resolution of infection in 34 cases (64.2%), whereas kpro explantation was required in 19 cases (35.8%). Infectious keratitis was associated with an increased risk for kpro explantation (HR: 3.09, 95% confidence interval, 1.92-4.79). CONCLUSIONS Infectious keratitis develops in approximately 17% of eyes after kpro implantation, with a higher rate of culture-positive bacterial than fungal keratitis. The observed rate of microbial keratitis suggests the need for additional topical antimicrobial prophylaxis in eyes at higher risk, such as those with preexisting cicatricial disease or postoperative persistent corneal epithelial defect formation.

To determine incidence, risks factors for, and outcomes of idiopathic vitritis (IV) after Boston type 1 keratoprosthesis (KPro) implantation.Retrospective, consecutive case series. Risk factors were analyzed between IV group and No IV group.IV occurred in 32/350 procedures (9.1%), for an average incidence of 0.02 cases per procedure-year. Presumed infectious keratitis was the only risk factor identified (HR = 7.65) Corneal necrosis and retinal detachment occurred significantly more frequently in IV group (allIV is associated with infectious keratitis, indicating that the vitritis may not be a sterile process. The increased incidence of subsequent complications leads to significantly decreased visual acuity and KPro retention in affected eyes.

Purpose To determine the incidence and recurrence of Boston type I keratoprosthesis (KPro)-associated endophthalmitis, and its microbiological profile, risk factors, and outcomes. Methods This is a retrospective study of 158 consecutive KPro procedures with a median follow-up of 78.4 months. Medical charts were reviewed for ocular history, contact lens and topical antibiotic use, visual acuity, and complications. For eyes with endophthalmitis, time to infection, culture results, and recurrences were collected. Cox regression analyses identified risk factors for endophthalmitis and compared the risk for visual failure, KPro retention, and globe loss between eyes with and without endophthalmitis. Results The incidence and recurrence rates of endophthalmitis were of 1.7% and 6.0% per procedure-year, respectively. First episodes occurred at a median of 18.6 months. Eight of 18 episodes (44%) were culture positive, isolating mainly Gram-positive bacteria (7 [88%]). Previous ocular burn (hazard ratio: 7.34, 95% confidence interval: 1.91-28.15), infectious keratitis (5.09, 1.70-15.22), corneal melt (4.55, 1.50-13.83), and postoperative contact lens wear (4.19, 1.17-15.04) were risk factors. Eyes with endophthalmitis did not have a higher risk for visual failure (1.74, 0.78-3.91) but were more likely to not retain the KPro (2.81, 1.15-6.88) and undergo evisceration (2.81, 1.15-6.88). All eyes lost ≥ 2 lines of vision during the endophthalmitis episode. Conclusions Endophthalmitis is rare but vision and globe threatening in eyes with KPro. Given the increased associated risk, corneal melts and infectious keratitis must be promptly treated, postoperative contact lenses should be considered on a case-by-case basis, and patients with ocular burns might require more aggressive antimicrobial prophylaxis.

There is currently no clinical risk-assessment tool allowing identification of patients at risk for developing uveal melanoma (UM) who might benefit from regular screening. As a first step toward the elaboration of such a tool, we systematically reviewed UM risk factors already established by meta-analysis.Two reviewers independently screened Pubmed, Medline, Embase, and Web of Science from their respective inception dates until July 2016 using a combination of keywords and MeSH terms. Eligible studies were meta-analyses or systematic reviews providing pooled odds ratios (ORs) of risk factors for UM development or sufficient information to calculate them. Methodological quality was evaluated using the Assessment of Multiple Systematic Reviews tool.Four meta-analyses with a mean methodological quality score of 65.9% (min: 54.5%; max: 72.7%) were included. The following significant risk factors were identified: atypical cutaneous nevi (OR 2.82, 95% CI 1.10-7.26), welding (OR 2.05, 95% CI 1.20-3.51), occupational cooking (OR 1.81, 95% CI 1.33-2.46), fair skin color (OR 1.80, 95% CI 1.31-2.47), light eye color (OR 1.75, 95% CI 1.31-2.34), common cutaneous nevi (OR 1.74, 95% CI 1.27-2.39), propensity to sunburn (OR 1.64, 95% CI 1.29-2.09), iris nevi (OR 1.53, 95% CI 1.03-2.27), and cutaneous freckles (OR 1.27, 95% CI 1.09-1.49). Non-significant factors included outdoor leisure activity, occupational sunlight exposure, latitude of birth, and hair color.Moderate quality of evidence determined nine significant risk factors for developing UM. Knowledge of these variables will assist researchers in the elaboration of a formal risk-assessment tool allowing clinicians to estimate susceptibility to the disease and necessity of regular screening.

Purpose (1) To propose the use of episcleral venous outflow (EVO) as an outcome marker of iStent surgery, and an EVO grading scale. (2) To determine the association of EVO with: (a) postoperative intraocular pressure (IOP) and medication burden; (b) iStent patency status. Patients and methods Retrospective cohort study including 151 glaucomatous eyes having undergone iStent-phacoemulsification surgery. Demographic and preoperative data (IOP, number of antiglaucoma medications, glaucoma type and stage, maximal IOP) were collected. Postoperatively, were recorded: IOP, number of antiglaucoma medications, occurrence of stent malpositioning or obstruction, and EVO scores based on the proposed scale (0: no laminar flow; 1+: faint laminar flow; 2+: marked laminar flow). A Kruskal-Wallis test determined the association between EVO, postoperative IOP, and medication burden. A multivariable-adjusted ordinal logistic regression was used for the association with iStent patency status. Results Patients with marked laminar flow (2+) were more likely to have a lower IOP (P=0.022) and fewer medications (P=0.009) at 1-year postoperatively than those with no laminar flow (0). No difference was found in postoperative IOP and number of medications when comparing patients having faint laminar flow (1+) with patients from the other 2 EVO categories (0 and 2+). iStent patency was associated with greater EVO as opposed to its obstruction (odds ratio, 4.73; 95% confidence interval, 1.74-12.9). No malpositioned stents were noted in our cohort. Conclusions The use of EVO as an outcome marker of iStent surgery is physiologically plausible. The proposed EVO grading scale is simple, comprises few categories, and is easily applicable in an in-office setting. The results of this study suggest this scale could be useful in the assessment of iStent functionality and encourage its further investigation in prospective studies.

There is a current need for interventions that provide information to stroke survivors in a patient-centred, interactive, personalized and flexible manner. To this purpose, a standardized but content-flexible patient education programme based on the International Classification of Functioning, Disability and Health (ICF) was developed. This study evaluated the effect of this programme on perceived self-efficacy.Single-blind, randomized, multi-centre controlled trial.Stroke patients undergoing neurological rehabilitation were enrolled. Perceived self-efficacy was measured with the Liverpool Self-Efficacy Scale. Secondary outcomes were life satisfaction and self-perception of the impact of the stroke on life, measured with the WHOQOL and the Stroke Impact Scale, respectively. Data obtained at baseline, post-intervention and 6-month follow-up were analysed using multi-level models of change.Two hundred and thirteen patients received either the ICF-based patient education (n = 110) or an attention-placebo (n = 103) control intervention. Over time, patients' self-efficacy (p.01) and participation (p.01) improved, while emotional functioning (p.01) deteriorated, although no significant between-group differences were observed. Explorative analyses showed that gender, loci of control, difficulty in accessing health services after discharge and life satisfaction were significant predictors of self-efficacy.There was no significant benefit of the ICF-based patient education in comparison with an attention-placebo control group. Considering the importance of the programme for the further implementation of the ICF and the need of developing effective health education interventions for stroke, the methodology used was reviewed and an updated version proposed.

The purpose of this study was to assess the feasibility of initiating primary cultures of corneal endothelial cells from patients suffering from Fuchs endothelial corneal dystrophy (FECD; MIM# 1036800). We also evaluated which conditions yielded the best results for culture. Twenty-nine patients undergoing Descemet stripping automated endothelial keratoplasty consented to the use of their excised Descemet's membrane for this study. Out of the 29 specimens, 18 successfully initiated a culture. Cell morphology varied between endothelial (rounded, slightly elongated cells, n = 12) and fibroblastic-like (thin and very elongated cells, n = 6). These differences in cell morphology were also observed with the normal human corneal endothelial cell cultures. The cultures that initially presented an endothelial morphology maintained their shape in subcultures. Clusterin expression was similar in FECD and normal endothelial cells. Transmission electron microscopy of FECD Descemet's membranes showed a high degree of various abnormalities generally found in this disease, such as a thickened Descemet's membrane, presence of a posterior banded layer, presence of a fibrillar layer and striated bodies of various sizes and periodicities. Patient's age was predictive of culture success, all younger FECD donors generating cultures of endothelial morphology. The absence of a fibrillar layer was also a factor associated with greater success. Culture success was not dependent on specimen size, specimen pigmentation, or patient's preoperative central corneal thickness. In conclusion, this paper shows for the first time that central Descemet's membranes of patients suffering from FECD possess proliferative endothelial cells that can be isolated and cultured without viral transduction, opening the way for new in vitro studies of this disease.

The impact of cancer on children can be assessed through various concepts including mental and physical health status and most significantly quality of life (QOL). It has been difficult to compare data collected through these instruments due to a lack of continuity or understanding of overlaps and gaps between them. To delineate the content of the most commonly used instruments in childhood cancer on an item-by-item basis, this study used standardized methods to link health information to the International Classification of Functioning, Disability, and Health (ICF) as well as World Health Organization (WHO) standard definitions of health and quality of life. MEDLINE, CINAHL, EMBASE, PsycINFO, Cancerlit, and Sociological Abstracts were searched from the inception of each database to June 15th, 2009 for health status and quality of life instruments. The six most common cancer-specific and generic instruments employed in primary research in childhood cancer were analyzed on an item-by-item basis by two content assessors specializing in ICF linking and WHO definitions of health and QOL, using a standardized iterative technique developed at the ICF Research Branch. We report the extent to which health status and QOL are represented in each instrument. Most measures emphasize a majority health status perspective according to WHO definitions of health. The generic instruments stress activities and participation domains over body functions or environment factors according to the ICF while cancer-specific instruments vary in their emphasis. Initial phase of coding agreement between assessors was in the substantial range (0.6–0.8 using Cohen’s kappa). A comprehensive and systematic content analysis of the most commonly employed health status and QOL instruments was conducted for this review. Two criteria were described as follows: the perspectives of the instruments (i.e., health vs. QOL) and the health content (according to ICF components). No single instrument demonstrated an ideal balance of content characteristics according to these criteria, and thus, each must be considered carefully relative to one’s particular research or clinical evaluative purpose.

To determine whether changes in health outcomes result from changes in domains of functioning and relevant environmental factors in musculoskeletal conditions.Longitudinal observational study on a convenience sample of 291 patients with low back pain, osteoarthritis, osteoporosis, rheumatoid arthritis and chronic widespread pain. The study was part of the MHADIE project. Data collection was performed at baseline, after 4 and 8 weeks using the ICF Core Sets for the corresponding musculoskeletal conditions. Multilevel models for change were used to determine which ICF categories explain the variability and change over time of the general, physical and mental health according to the SF-36.There are only small fluctuations in the health outcomes. These are related to functions of the locomotor apparatus, such as muscle power, and to activities and participation domains related to them, such as lifting and carrying objects. A large amount of baseline variance is explained with a relatively small number of ICF categories of functioning.This study presents a list of functioning problems and environmental factors relevant to map out both the patterns and the variations in the experience of living with a chronic and painful condition. These are intervention targets common across MSC conditions.

Purpose The International Classification of Functioning, Disability and Health (ICF) has proven to be a valuable framework for vocational rehabilitation (VR). No reliable and valid ICF-based instruments to capture work functioning is known, hence, the aims of this study were: (1) to outline the process for developing an ICF-based questionnaire, the Work Rehabilitation Questionnaire (WORQ) to assess functioning in VR and (2) to report preliminary psychometric evidence. Methods ICF categories were selected from the ICF Core Sets for VR using explorative Rasch-analysis and VR literature review. Questions were worded to assess identified ICF categories. WORQ was translated from English to German. Psychometrics for the German version of WORQ was examined in one VR centre in Switzerland. Results 44 ICF categories were selected which resulted in 36 questions related to functioning. The psychometric evaluation of WORQ showed high test-retest reliability (Spearman correlation 0.79) (n = 53) and good internal consistency (Cronbachs Alpha 0.88) (n = 74) WORQ showed moderate correlation with Beck Depression Inventory II (Spearman correlation 0.511) and low correlation (Spearman correlation -0.353) with SF-36. Conclusions WORQ appears to be a reliable, ICF-based questionnaire to evaluate functioning in VR, easy to administer by health or vocational professionals. The additional information gained when using WORQ would contribute to improving interdisciplinary understanding of the patient's situation and therefore support the integrative planning of the return-to-work process or engagement in gainful employment. However, further studies are needed to further examine its use in clinical practice and research, when validated in other patient populations and settings.

OBJECTIVE: To determine which environmental factors are associated with performance when controlling for capacity, using the International Classification of Functioning, Disability and Health (ICF).METHODS: A psychometric study using a sample of 296 persons with musculoskeletal health conditions as a case in point. The following steps were carried out: (i) Rasch analyses created 2 interval measurement scales, capacity and performance, based on 22 Activities and Participation ICF categories that had been rated as capacity and performance. Capacity and performance scores, ranging from 0 (low level) to 100 (high level) were calculated; (ii) group lasso regression was used to identify the environmental factors associated with a person’s performance when controlling for capacity. Gender, age and health condition were forced to remain in the model.RESULTS: A capacity scale based on 16 ICF categories (rated as capacity) and a performance scale based on 18 categories (rated as performance) were created. Thirteen environmental factors ICF categories covering the physical, social, attitudinal and political environment were identified as highly associated with patient’s performance.CONCLUSION: Using an exclusively statistical approach this study identified environmental factors associated with a person’s performance.

Background: Lived health is a person’s level of functioning in his or her current environment and depends both on the person’s environment and biological health. Our study addresses the question whether biological health or lived health is more predictive of self-reported general health (SRGH). Methods: This is a psychometric study using cross-sectional data from the Spanish Survey on Disability, Independence and Dependency Situation. Data was collected from 17,739 people in the community and 9,707 from an institutionalized population. The following analysis steps were performed: (1) a biological health and a lived health score were calculated for each person by constructing a biological health scale and a lived health scale using Samejima’s Graded Response Model; and (2) variable importance measures were calculated for each study population using Random Forest, with SRGH as the dependent variable and the biological health and the lived health scores as independent variables. Results: The levels of biological health were higher for the community-dwelling population than for the institutionalized population. When technical assistance, personal assistance or both were received, the difference in lived health between the community-dwelling population and institutionalized population was smaller. According to Random Forest’s variable importance measures, for both study populations, lived health is a more important predictor of SRGH than biological health. Conclusions: In general, people base their evaluation of their own health on their lived health experience rather than their experience of biological health. This study also sheds light on the challenges of assessing biological health and lived health at the general population level.

Purpose To evaluate the functionality of a corneal endothelium reconstituted by injection of corneal endothelial cells (CEC) in the anterior chamber of a feline model. Methods We operated the right eyes of 16 animals. Eight underwent central endothelial scraping and injection with 2 × 10(5) (n = 4) or 1 × 10(6) (n = 4) feline CEC supplemented with Y-27632 and labeled with 3,3'-Dioctadecyl-5,5'-Di(4-Sulfophenyl)Oxacarbocyanine (SP-DiOC18[3] or DiOC). After total endothelial scraping, two eyes were injected with 1 × 10(6) labeled CEC and Y-27632. The central (n = 3) or entire (n = 3) endothelium was scraped in six eyes followed by Y-27632 injection without CEC. Subjects were positioned eyes down for 3 hours. Outcomes included graft transparency, pachymetry, CEC morphometry, histology, electron microscopy, and function and wound healing-related protein immunostaining. Results Postoperatively, corneas grafted with 2 × 10(5) CEC and centrally scraped controls displayed the best transparency and pachymetry. Corneas grafted with 1 × 10(6) CEC yielded intermediate results. Entirely scraped controls remained hazy and thick. Histopathology revealed a confluent endothelial monolayer expressing sodium-potassium adenosine triphosphatase (Na(+)/K(+)-ATPase) and zonula occludens-1 (ZO-1) in corneas grafted with 2 × 10(5) CEC and centrally scraped controls, a nonuniform endothelial multilayer without expression of functional proteins in centrally scraped corneas grafted with 1 × 10(6) CEC, and a nonfunctional fibrotic endothelium in entirely scraped grafts and controls. Expression of DiOC in grafts was scarce. Conclusions Injected CEC contributed little to the incompletely functional endothelium of grafted corneas. Y-27632 injection without CEC following scraping reconstituted the healthiest endothelium. Further studies investigating the therapeutic effect of Y-27632 alone are needed to validate these conclusions.

Aim: our aims were to (1) describe the conceptual basis of popular generic instruments according to World Health Organization (WHO) definitions of functioning, disability, and health (FDH), and quality of life (QOL) with health-related quality of life (HRQOL) as a subcomponent of QOL; (2) map the instruments to the International Classification of Functioning, Disability and Health (ICF); and (3) provide information on how the analyzed instruments were used in the literature. This should enable users to make valid choices about which instruments have the desired content for a specific context or purpose. Method: child health-based literature over a 5-year period was reviewed to find research employing health status and QOL/HRQOL instruments. WHO definitions of FDH and QOL were applied to each item of the 15 most used instruments to differentiate measures of FDH and QOL/HRQOL. The ICF was used to describe the health and health-related content (if any) in those instruments. Additional aspects of instrument use were extracted from these articles. Results: many instruments that were used to measure QOL/HRQOL did not reflect WHO definitions of QOL. The ICF domains within instruments were highly variable with respect to whether body functions, activities and participation, or environment were emphasized. Interpretation: there is inconsistency among researchers about how to measure HRQOL and QOL. Moreover, when an ICF content analysis is applied, there is variability among instruments in the health components included and emphasized. Reviewing content is important for matching instruments to their intended purpose

Objective: This study aimed to explore to what extent the data collected for patients with low back pain, breast cancer, and stroke, based on the International Classification of Functioning, Disability and Health (ICF) Checklist, reflect the hypothesized single latent dimension functioning and whether the ICF qualifier scale expresses a clearly defined ordered sequence of response options. Design: Data including ratings of 56 ICF categories for low back pain, 54 for breast cancer, and 84 for stroke were analyzed using the Rasch model. Results: For each health condition, most of the ICF categories fit the Rasch model. In most of them, one or two of the four threshold estimates were reversed before collapsing the response options. The collapsing strategy 01122 was proposed. Conclusions: The fit residual statistics showed that most of the ICF categories selected for each of the health conditions reflect the single latent variable functioning. The ordering of the ICF qualifier scale was not consistent with the intended order.

To investigate the possibility of constructing a multiprofessional cross-cultural measure of functioning after stroke across categories of the International Classification of Functioning, Disability and Health (ICF).Data on 757 stroke survivors from China, Germany, Italy, and Sweden, including ratings of 15 categories from the Brief ICF Core Set for stroke, were analyzed using the Rasch model. Unidimensionality, reliability, fit of the ICF categories to the model, ordering of response options of the ICF qualifier, and presence of differential item functioning (DIF) were studied.Of the 15 ICF categories, response options for 7 categories were collapsed, 5 categories were deleted due to misfit, and 4 ICF categories showed DIF for country and were accordingly split into country-specific categories. The proposed final clinical measure consists of 20 ICF categories (6 categories were country-common) with an overall fit statistic of χ2180 = 184.87, P = .386, and a person separation index of r = 0.72, which indicates good reliability. Based on an individual's functioning after stroke, the ratings across the different ICF categories can be summed on an interval scale ranging from 0 to 100.A construction of a cross-cultural clinical measure after stroke based on ICF categories across body functions, structures, and activities and participation was possible. With this kind of clinical measure, stroke survivors' functional levels can be compared even across countries. Despite the promising results, further studies are necessary to develop definitive measures based on ICF categories.

Background The impact of ankylosing spondylitis (AS) on a patient’s life can be considerable. The International Classification of Functioning, Disability and Health (ICF) is a model to systematically classify and describe functioning, disability, and health in human beings. However no ICF-based patient-reported outcome measure has been developed. Objectives To develop a measure to assess health in patients with AS, the ASAS (Assessments of SpondyloArthritis international Society (ASAS)) Health Index, based on the Comprehensive ICF Core Set for AS. Methods Development has beenperformed in five phases: Ia Preparatory: Development of an item pool representing the categories of the Comprehensive ICF Core Set for AS, Ib Patient meeting: Patient preference and weighting of the items per ICF category, II 1st postal patient survey: Item reduction (within and across ICF categories), III Expert consultation: Agreement on item reduction, IV 2nd postal survey: Validation of the draft version and further item reduction, V consensus meeting: Agreement on a final version. Results Phase I: The item pool contained 251 items in 44 categories by linking existing items from over 60 questionnaires to the comprehensive ICF core set for AS. Phase II was performed based on data collected along an international cross sectional study among 1915 AS patients (mean age 51.2±3.6, 53% male, BASDAI 5.5±2.4) in 4 continents. For 82 items of the functioning part a unidimensional scale, fit to the Rasch model and absence of Differential Item Function (DIF) could be confirmed. Phase III: An expert committee selected 50 functioning items using predefined selection criteria. Phase IV: An international cross sectional study with 628 AS patients (mean age 48.5±14.2, 51.6% male, BASDAI 5.6±2.3) was conducted in 4 continents. Misfit was identified in 4 items and DIF in 15 items. More than 50% of the items showed a residual correlation between each other above a value of 0.2 in the initial round. Phase 5: Based on results of the analyses in step 4, the consensus members agreed on 17 final items. In the 17 items fit to the model, no residual correlation and absence of constant DIF could be confirmed with a Person-Separation Index of 0.82. The item location has been shown to be 0.00 ± 1.84 with a fit residual of 0.06 ± 1.24 and the person location has been shown to be 0.01 ± 1.80 with a fit residual of -0.30 ± 0.67. The chi-square probability was 0.73. Conclusions The ASAS HI measure contains 17 dichotomous items addressing categories of pain, emotional functions, sleep, sexual functions, mobility, self-care, community life and employment. In covering much of the ICF Core Set for AS, these items represent a whole range of abilities of patients with AS. The questionnaire will be translated and further tested for sensitivity to change. ASAS HI can be used in clinical trials and clinical practiceas a new composite index that captures relevant information on the health status of the patients. Disclosure of Interest None Declared

Background The burden of ankylosing spondylitis (AS) can be considerable. The patients suffer from pain, stiffness and fatigue, and they are limited in their activities and restricted in social participation. The International Classification of Functioning, Disability and Health (ICF), a model to systematically classify and describe functioning, disability and health in human beings, has been used by the Assessments of SpondyloArthritis international Society (ASAS) as a basis to define a core set of items that are typical and relevant for patients with AS. However, no ICF-based patient-reported outcome measure has been developed for AS patients. Objectives To develop a measure to assess the burden of AS, the AS Health Index, based on the Comprehensive ICF Core Set for AS. Methods Development of this health index is being performed in five phases. I. Preparatory: Development of a pool of items representing the categories of the Comprehensive ICF Core Set, Linkage of various assessment tools for functioning and health to ICF categories II. 1st postal patient survey: Item reduction with Factor Analysis, Rasch Analysis, Spearman rank correlation coefficient III. Expert consultation: Agreement on item reduction with Nominal Consensus Process IV. 2nd postal patient survey: Validation of the draft version and further item reduction, Testing psychometric properties, Rasch Analysis V. Consensus Meeting: Agreement on a final version with Nominal Consensus Process Results The first three phases have been completed. During the preparatory phase (Phase 1): a pool of 251 items in 44 categories was collected from various instruments (identified through literature search) which focus on symptoms and functioning in patients with AS. Phase 2: An international cross sectional study with 1915 AS patients (mean age 51.2±3.6, 53% male, BASDAI 5.5±2.4) was conducted in 4 continents. In 82 items of the functioning part a unidimensional scale, fit to the Rasch model and absence of Differential Item Function could be confirmed. 32 items of the environmental factors part showed a significant correlation between person score and ICF category (correlation coefficient between 0.04 - 0.45). Phase 3: Based on results of the analyses in step 2, an expert committee selected 50 functioning items and 16 environmental factor items using predefined selection criteria (clinimetric properties, ease of wording, coverage of the whole range of ability). Conclusions The item pool has been successfully reduced from 251 down to 66 items. In covering much of the ICF Core Set for AS, these items represent a whole range of abilities of patients with AS. This draft version will be tested in a second survey to create a first version of the ASAS Health Index. The final measure can be used in clinical trials and cohort studies as a new composite index that captures relevant information on the health status of the patients. Disclosure of Interest None Declared

Background Patients with ankylosing spondylitis (AS) suffer from pain, stiffness and fatigue, are limited in their activities and restricted in social participation as it is categorized in the International Classification of Functioning, Disability and Health (ICF). Awareness has grown that the experience of health is the product of the interaction between the disease related on the one hand and a series of contextual factors in the person and environment. Environmental factors (EF) are defined as elements external to the individual that can influence functioning and can be facilitators or barriers The most important EF for patients with AS has been identified in the ASAS (Assessments of SpondyloArthritis international Society) Core set for patients with AS. However, there is limited understanding of the relationship and it’s extend between EF and the health of patients with AS. Objectives To select a core set of EF which influence importantly self-reported functioning in patients with AS. Methods An item pool of candidate EF-items was developed by linking existing questionnaire-items to the EF-categories of the ASAS Core Set for AS. The label of being a barrier or a facilitator has been designated to each item. The EF item pool has been tested together with the item set of the ASAS Health Index (ASAS HI) in two cross-sectional studies. The selection of the EF item set is based on the correlation of each individual item to the sum score of the ASAS HI. Results The initial item pool exists of 53 items addressing categories of e1 ‘products and technologies’, e3 ‘support and relationship’, e4 ‘attitudes’ and e5 ‘health services’. After the 1 st postal survey 37 items were deleted because of low non-significant correlation between EF item and ASAS HI sum score. Out of the remaining 16 items 9 were selected after the 2 nd postal survey to build the final EF item set. Of these, 3 items serves as a facilitator and 6 items serves as a barrier. Conclusions The EF item set gives an overview on most important domains addressing support and relationship, attitudes of the patient and health services. Health professionals can assess with this pool in which areas the patient might need special assistance and researchers need to take EF into account when interpreting data on self-reported health. EF may often impact functioning not as single categories but as complex arrays of multiple EFs. Further research is needed to enlarge the understanding of the influence of EF as a complex area on health status in specific disease states. References Boonen et al. ASAS/WHO ICF Core Sets for ankylosing spondylitis (AS): how to classify the impact of AS on functioning and health. Ann Rheum Dis 2010;69:102-107. Disclosure of Interest None Declared

Background: lived health and biological health are two different perspectives of health introduced by the International Classification of Functioning, Disability and Health (ICF). Since in the concept of lived health the impact of the environment on biological health is inherently included, it seems intuitive that when identifying the environmental determinants of health, lived health is the appropriate outcome. The Multilevel Item Response Theory (MLIRT) model has proven to be a successful method when dealing with the relation between a latent variable and observed variables. The objective of this study was to identify environmental factors associated with lived health when controlling for biological health by using the MLIRT framework.Methods: we performed a psychometric study using cross-sectional data from the Spanish Survey on Disability, Independence and Dependency Situation. Data were collected from 17,303 adults living in 15,263 dwellings. The MLIRT model was used for each of the two steps of the analysis to: (1) calculate people’s biological health abilities and (2) estimate the association between lived health and environmental factors when controlling for biological health. The hierarchical structure of individuals in dwellings was considered in both models.Results: social support, being able to maintain one’s job, the extent to which one’s health needs are addressed and being discriminated against due to one’s health problems were the environmental factors identified as associated with lived health. Biological health also had a strong positive association with lived health.Conclusions: this study identified environmental factors associated with people’s lived health differences within and between dwellings according to the MLIRT-model approach. This study paves the way for the future implementation of the MLIRT model when analysing ICF-based data