Development and validation of a patient-reported outcome measure for systemic sclerosis: the EULAR Systemic Sclerosis Impact of Disease (ScleroID) questionnaire.

OBJECTIVES: Patient-reported outcome measures (PROMs) are important for clinical practice and research. Given the high unmet need, our aim was to develop a comprehensive PROM for systemic sclerosis (SSc), jointly with patient experts. METHODS: This European Alliance of Associations for Rheumatology (EULAR)-endorsed project involved 11 European SSc centres. Relevant health dimensions were chosen and prioritised by patients. The resulting Systemic Sclerosis Impact of Disease (ScleroID) questionnaire was subsequently weighted and validated by Outcome Measures in Rheumatology criteria in an observational cohort study, cross-sectionally and longitudinally. As comparators, SSc-Health Assessment Questionnaire (HAQ), EuroQol Five Dimensional (EQ-5D), Short Form-36 (SF-36) were included. RESULTS: Initially, 17 health dimensions were selected and prioritised. The top 10 health dimensions were selected for the ScleroID questionnaire. Importantly, Raynaud's phenomenon, impaired hand function, pain and fatigue had the highest patient-reported disease impact. The validation cohort study included 472 patients with a baseline visit, from which 109 had a test-retest reliability visit and 113 had a follow-up visit (85% female, 38% diffuse SSc, mean age 58 years, mean disease duration 9 years). The total ScleroID score showed strong Pearson correlation coefficients with comparators (SSc-HAQ, 0.73; Patient's global assessment, Visual Analogue Scale 0.77; HAQ-Disability Index, 0.62; SF-36 physical score, -0.62; each p<0.001). The internal consistency was strong: Cronbach's alpha was 0.87, similar to SSc-HAQ (0.88) and higher than EQ-5D (0.77). The ScleroID had excellent reliability and good sensitivity to change, superior to all comparators (intraclass correlation coefficient 0.84; standardised response mean 0.57). CONCLUSIONS: We have developed and validated the EULAR ScleroID, which is a novel, brief, disease-specific, patient-derived, disease impact PROM, suitable for research and clinical use in SSc.

The Patient Experienced Symptom State (PESS): a patient-reported global outcome measure that may better reflect disease remission status.

OBJECTIVES: In RA, Patient Acceptable Symptom State assesses disease from the patient's perspective, which does not correspond either to disease remission or to full control of disease impact. This study aims to explore the properties of a novel multilevel Patient Experienced Symptom State (PESS). METHODS: This was a cross-sectional analysis of two datasets of patients with RA. PESS was assessed through the question: 'Consider how your RA has affected you. If you remain in the coming months as you have been the last week, how would you rate your condition?', with five levels (from 'very bad' to 'very good'). Construct validity of PESS was assessed against validated disease activity [DAS28, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)] and impact measures [RA Impact of Disease (RAID) and modified HAQ]. Multiple pairwise comparisons between groups and receiver-operating characteristic curves with Youden Index were performed. RESULTS: A total of 1407 patients [74% female, mean (S.d.) age 53.5 (13.4) years, mean disease duration 14.3 (12.0) years and mean DAS28 3.0 (1.5)] were analysed. Overall, 16.3% considered themselves as being in 'very good', 21.6% in 'good' and 31.9% in 'acceptable' state. Disease activity and impact measures differed significantly across the five levels (P < 0.01). Cut-off values corresponding to 'good' and 'very good' PESS states were in the range of low disease activity/remission (for 'good' and 'very good': DAS28-ESR-4v ≤2.6/≤2.3; CDAI ≤5.0/≤3.1; SDAI ≤5.1/≤3.8, respectively) and very low disease impact (RAID domains all ≤1). CONCLUSION: PESS 'very good' status corresponds to currently recommended targets for RA management and reflects full control of disease impact. PESS appears to be an easy-to-use and relevant measure in the evaluation of patients with RA.

Psychometric performance of the PAncreatic CAncer disease impact (PACADI) score.

BACKGROUND/OBJECTIVE: Pancreatic Cancer Disease Impact (PACADI) score measures the impact of pancreatic cancer (PC) on important health dimensions, selected by patients. The aim of this single center study was to test the psychometric performance of the Pancreatic Cancer Disease Impact (PACADI) score. METHODS: Patients with suspected pancreatic cancer (PC) completed PACADI, the EuroQol-5D (EQ-5D index) and Edmonton Symptom Assessment System (ESAS) in this longitudinal observational study. Measures were compared across patients with PC (n = 210), other malignant lesions (OML) (n = 109) and non-malignant lesions (NML) (n = 41). Associations, test-retest and internal consistency reliability, longitudinal changes, sensitivity to change and prediction of mortality during the first year were examined in patients with PC. RESULTS: The three measures discriminated between PC and OML. The PACADI score correlated strongly at baseline (n = 199)/after three months (n = 85) with the EQ-5D index and ESAS "sense of well-being" (0.64 and 0.66/0.73 and 0.69, p < 0.001, respectively), showed high test-retest reliability (ICC 0.84) and very good internal consistency reliability (Cronbach's alpha 0.81-0.85) across all visits. Scores improved over time at 3, 6, 9 and 12 months for survivors, and standardized response mean (SRM) for improvement between 2 and 3 months (n = 44) was 0.80 (PACADI), -0.59 (EQ-5D index) and 0.69 (ESAS "sense of well-being"). The PACADI score significantly predicted mortality within the first year (p = 0.02) in contrast to the EQ-5D index and ESAS "sense of well-being". CONCLUSION: This study showed satisfactory psychometric performance of the PACADI score. The results support its use in clinical practice and intervention trials.

Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) in a Norwegian population of patients with neovascular age-related macular degeneration compared to a control population.

BACKGROUND: Although visual acuity and optical coherence tomography (OCT) are most widely used as outcomes in treatment of neovascular age-related Macular Degeneration (nAMD), patient reported outcome measures are increasingly recognized. National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) was developed to capture the perceived visual function. Yet, evidence of psychometric performance in the target population is required. The aim of this study was to examine the psychometric properties of NEI-VFQ 25 in a Norwegian cohort of newly diagnosed nAMD patients followed with a Treat and Extend (T/E) protocol. METHODS: Patients receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection treatment according to a T/E protocol completed a Norwegian translation of NEI-VFQ 25, EuroQoL Health Questionnaire (EQ-5D), and Patient acceptable symptom state (PASS 5) at baseline, 3, 6 and 12 months. In addition, a control population completed the same questionnaires. Visual acuity was assessed with LogMar for best/treated eye. Validity testing comprised face validity by a 0-10 numeric rating scale about relevance of NEI-VFQ 25 as well as regression analyses and correlations between NEI-VFQ 25 and other relevant variables. Reliability was examined with Intraclass Correlation Coefficient (ICC) and Cronbach's alpha for internal consistency were performed. Responsiveness, discriminatory power and predictive value were also explored. RESULTS: Number of respondents at baseline, after 3, 6 and 12 months was 197, 186, 176 and 168, respectively. The control population comprised 26 individuals. Face validity of NEI-VFQ 25 had a mean (SD) of 7.8 (1.7) (n = 84). NEI-VFQ was significantly correlated to visual acuity and PASS 5 as well as EQ-5D at baseline. Reliability (ICC) of the overall and sub scores for the patients/controls ranged from 0.49-0.97/0.59-0.97. Cronbach's alpha was 0.61-0.85. Discriminatory power was confirmed by significant differences of the overall score between controls and patients (P < 0.001). NEI-VFQ 25 indicates responsiveness showing overall score improved significantly (P ≤ 0.001) from baseline to 3 months. NEI-VFQ 25, general health and visual acuity at baseline were the strongest predictors for how patients reported vision after 6 months follow-up. CONCLUSION: NEI-VFQ 25 showed acceptable psychometric performance, which supports that the Norwegian version can be used to monitor patients treated for nAMD.

Survival, Complications and Patient Reported Outcomes after Pancreatic Surgery.

BACKGROUND: Long-term effects of complications in pancreatic surgery have not been systematically evaluated. The objectives were to assess potential effects of complications on survival and patient reported outcomes (PROs) as well as feasibility of PRO questionnaires in patients with periampullary and pancreatic tumors. METHODS: From October 2008 to December 2011, 208 patients undergoing pancreatic surgery were included in a prospective observational study. ESAS, EORTC QLQ-C30 and QLQ-PAN26 questionnaires were completed at inclusion, then every third month. Complications were recorded according to the Clavien-Dindo (CD) classification and Comprehensive Complication Index (CCI). RESULTS: 148 complications were registered in 100 patients (48%), 36 patients (17%) had CD IIIa or above. 125 patients (60%) completed baseline questionnaires, 80 (39%) responded after three and 54 (28%) after six months. Complications were associated with reduced long-term survival in patients with pancreatic ductal adenocarcinoma (PDAC) (p = 0.049) and other malignant diseases. No significant relationship was found between complications and PROs, except for anxiety, which was significantly increased in patients with complications. CONCLUSION: Postoperative complications led to increased anxiety at 3 months after surgery and were associated with reduced long-term survival in patients with malignancy. A short, patient derived, disease specific questionnaire is required in the clinical research context.

Preoperative cognitive function predicts survival in patients with resectable pancreatic ductal adenocarcinoma.

BACKGROUND: The purpose of this prospective study was to evaluate whether pre-surgery health-related quality of life (HRQoL) and subjectively rated symptom scores are prognostic factors for survival in patients with resectable pancreatic ductal adenocarcinoma (PDAC). METHODS: Patients undergoing pancreatic resection for PDAC completed the Edmonton Symptom Assessment System (ESAS) and the EORTC QLQ-C30 and QLQ-PAN26 questionnaires preoperatively. Patient, tumor and treatment characteristics, recurrence and survival were registered. RESULTS: Sixty-six consecutive patients underwent R0/R1 resection for PDAC. Baseline ESAS and EORTC questionnaire compliance was 44/66 (67%) with no statistically significant differences between compliers (n = 44) and non-compliers (n = 22) when comparing clinicopathological parameters and survival. Univariable analyses showed that three symptoms (nausea, dry mouth, cognitive function) and two clinicopathological factors (CA 19-9 > 400 U/ml, lymph node ratio > 0.1) were significantly associated with shorter survival (p < 0.05). In multivariable analysis, cognitive function was the only independent predictor for survival: hazard ratio = 0.35 (95%CI 0.13-0.93) for high vs low cognitive function. Median survival times for patients with high and low cognitive function were 21 and 10 months, respectively (p < 0.001). CONCLUSION: Presurgery cognitive function is a significant independent predictor of survival in patients with resectable PDAC. Thus, presurgery patient reported outcomes may provide as strong prognostic information as clinicopathological factors.

A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative.

INTRODUCTION: The objective was to develop a questionnaire that can be used to calculate a score reflecting the impact of psoriatic arthritis (PsA) from the patients' perspective: the PsA Impact of Disease (PsAID) questionnaire. METHODS: Twelve patient research partners identified important domains (areas of health); 139 patients prioritised them according to importance. Numeric rating scale (NRS) questions were developed, one for each domain. To combine the domains into a single score, relative weights were determined based on the relative importance given by 474 patients with PsA. An international cross-sectional and longitudinal validation study was performed in 13 countries to examine correlations of the PsAID score with other PsA or generic disease measures. Test-retest reliability and responsiveness (3 months after a treatment change) were examined in two subsets of patients. RESULTS: Two PsAID questionnaires were developed with both physical and psychological domains: one for clinical practice (12 domains of health) and one for clinical trials (nine domains). Pain, fatigue and skin problems had the highest relative importance. The PsAID scores correlated well with patient global assessment (N=474, Spearman r=0.82-0.84), reliability was high in stable patients (N=88, intraclass correlation coefficient=0.94-0.95), and sensitivity to change was also acceptable (N=71, standardised response mean=0.90-0.91). CONCLUSIONS: A questionnaire to assess the impact of PsA on patients' lives has been developed and validated. Two versions of the questionnaire are available, one for clinical practice (PsAID-12) and one for clinical trials (PsAID-9). The PsAID questionnaires should allow better assessment of the patient's perspective in PsA. Further validation is needed.

Improved survival and quality of life in patients undergoing R1 pancreatic resection compared to patients with locally advanced unresectable pancreatic adenocarcinoma.

OBJECTIVE: To prospectively record the clinical consequences of R1 resection of pancreatic adenocarcinoma compared to patients with locally advanced tumours not undergoing surgery. BACKGROUND: Surgery is the only potentially curative treatment of pancreatic cancer, and postoperative safety is increasing. The rate of R1 resections might also increase unintentionally as surgical procedures with curative goal become more comprehensive, and the clinical outcome requires further prospective evaluation. MATERIAL AND METHODS: Prospective observational cohort study from October 2008 to December 2010. Outcome after R1 resection (group 1, surgery, n = 32) and conservative palliative chemoradiation/endoscopy (group 2, no surgery, n = 56) is compared with survival and longitudinal patient-reported quality of life (QoL) as endpoints. QoL was assessed by the Edmonton Symptom Assessment System (ESAS). RESULTS: Demographic characteristics and tumour diameters were similar in both groups: 38.0 (31.3, 49.8) mm in group 1 versus 44.0 (39.6, 49.1) mm in group 2 (p = 0.18). Perioperative morbidity was 25% with no mortality. Disease-specific survival was 18.0 (14.5, 23.8) months in group 1 versus 8.1 (4.8, 10.1) months in group 2 (p < 0.0001). Overall survival was 11 (7.8, 14.4) months. Reduction in fatigue was significantly improved in the surgery group 6, 12, and 19 weeks after baseline, whereas reduction in global health was significantly better in group 2. CONCLUSION: Radical removal (R0 resection) is the primary aim of surgery, but also R1 resection seems to improve survival and QoL, compared to outcome in patients with locally advanced tumours not undergoing surgery.

Development and preliminary validation of the pancreatic cancer disease impact score.

OBJECTIVE: Patient-reported outcomes are important for clinical practice and research, and should reflect what patients perceive as important. The objective of this study was to develop and preliminarily validate a brief, patient-derived, disease-specific tool, the pancreatic cancer disease impact (PACADI) score. METHODS: The development was performed in two phases. Forty-one patients with confirmed pancreatic cancer (PC) selected dimensions of health related to the impact of the disease. A weighting of the eight most frequently reported dimensions was performed in a second sample of 80 PC patients who also rated the impact on eight numeric rating scales (NRS, range 0 to 10). The relative weights and the scores from the NRS were used to compute the PACADI score (range 0 to 10). The patients also completed Edmonton Symptom Assessment System (ESAS) and EQ-5D. RESULTS: Dimensions reported by more than 20% of the patients were included in the PACADI score (relative weights in parenthesis): pain/discomfort (0.16), fatigue (0.16), anxiety (0.15), bowel/digestive problems (0.14), loss of appetite (0.13), dry mouth (0.11), itchiness (0.08), and nausea (0.07). The PACADI score in the 80 PC patients had a mean (SD) value of 3.26 (2.06) (95% CI 2.80, 3.71), was moderately to strongly correlated to ESAS sense of well-being (r = 0.69) and EQ-5D (r = -0.52), and discriminated significantly between patients with and without PC. CONCLUSION: The PACADI score is a new eight-item, patient-derived, disease-specific measure. Preliminary validation regarding construct validity and discrimination encourages further validation in independent patient samples.

Knowledge and Awareness of Non-Technical Skills Over the Course of an Educational Program in Nursing - A Repeated Cross-Sectional Study.

Background: Non-technical skills (NTS) play an important role in preventing adverse events during hospitalization. Knowledge, awareness and mastery of NTS becomes important key factors in preventing errors. Current status of students and supervisor's knowledge and awareness of NTS are needed in order to construct an educational plan for improvement. Purpose: To examine knowledge and awareness of NTS over the course of continuing education of nurse anaesthetists, emergency care nurses, critical care nurses, and operating room nurses. Methods: A descriptive, repetitive cross-sectional design with a questionnaire was used to evaluate knowledge and awareness in students and their supervisors about NTS at two different time points during the educational program. Cross tabulations were used in comparisons across specialties and between students and supervisors, frequencies to identify the levels of self-reported knowledge/importance/focus in clinical practice/ impact on adverse events. Results: The results showed that there was a numeric difference between the reported knowledge/focus in clinical practice on the one hand and importance/ impact on adverse events on the other, and that this gap was reduced after 12 months of education with special focus on NTS. There was no difference across specialties. Supervisors had higher focus on NTS in clinical practice and on the impact on adverse events, than students at both measurements. Conclusion: These data suggest that NTS may have important potential for improvement if included into learning programs both in education and clinical practice. Integration of NTS in various learning activities seems to strengthen students' competence about NTS.

EULAR recommendations for the role of the nurse in the management of chronic inflammatory arthritis.

OBJECTIVES: The authors aim to develop European League Against Rheumatism recommendations for the role of the nurse in the management of patients with chronic inflammatory arthritis, to identify a research agenda and to determine an educational agenda. METHODS: A task force made up of a multidisciplinary expert panel including nurses, rheumatologists, occupational therapist, physiotherapist, psychologist, epidemiologist and patient representatives, representing 14 European countries, carried out the development of the recommendations, following the European League Against Rheumatism standardised operating procedures. The task force met twice. In the first meeting, the aims of the task force were defined, and eight research questions were developed. This was followed by a comprehensive, systematic literature search. In the second meeting, the results from the literature review were presented to the task force that subsequently formulated the recommendations, research agenda and educational agenda. RESULTS: In total, 10 recommendations were formulated. Seven recommendations covered the contribution of nurses to care and management: education, satisfaction with care, access to care, disease management, psychosocial support, self-management and efficiency of care. Three recommendations focused on professional support for nurses: availability of guidelines or protocols, access to education and encouragement to undertake extended roles. The strength of the recommendations varied from A to C, dependent on the category of evidence (1A-3), and a high level of agreement was achieved. Additionally, the task force agreed upon 10 topics for future research and an educational agenda. CONCLUSION: 10 recommendations for the role of the nurse in the management of chronic inflammatory arthritis were developed using a combination of evidence-based and expert consensus approach.

Performance of the Rheumatoid Arthritis Impact of Disease (RAID) score in relation to other patient-reported outcomes in a register of patients with rheumatoid arthritis.

OBJECTIVE: Delegates at the Outcome Measures in Rheumatology (OMERACT) 10 conference (Borneo, 4-8 May 2010) questioned how the new seven-domain Rheumatoid Arthritis Impact of Disease (RAID) score performs as a global measure. Score distributions and associations between the RAID score and patient-reported outcomes (PROs) and demographic variables were examined in a large sample of rheumatoid arthritis (RA) patients. METHODS: 1086 patients in the Oslo RA Register responded to a postal survey with commonly used PROs. Bivariate associations between the RAID score and other measures are reported as Pearson correlation coefficients. RESULTS: The mean RAID was 3.37 ± 2.17. The distribution of the RAID score showed a slight floor effect: 17.5% had a score between 0 and 1, and 14.4% between 1 and 2, whereas only 1.0% and 0.3% had scores between 8 and 9, and 9 and 10, respectively. Correlations between the RAID score and the patient global assessment, Rheumatoid Arthritis Disease Activity Index, Short-Form (SF)-6D and EQ-5D were 0.82, 0.82, -0.77 and -0.73, respectively. Strong correlation was also seen between RAID and pain, the domain with highest weight, whereas correlations to measures of other RAID domains were moderate. The RAID score was higher in women than men (3.49 vs 2.95, p=0.001). CONCLUSION: The RAID score was correlated more strongly to other global measures than to PROs, reflecting single health domains.

Patient-reported outcome measures in the management of neovascular age-related macular degeneration: a 1-year prospective study.

OBJECTIVE: To prospectively explore the following patient-reported outcome measures (PROMs) in the management of neovascular age-related macular degeneration (nAMD): (1) self-reported visual function, (2) symptom-state, (3) general-health and (4) satisfaction of treatment. METHODS AND ANALYSIS: Corresponding to the four PROMs, participants responded to the following questionnaires: (1) National Eye Institute Visual-Functioning-Questionnaire (NEI-VFQ-25), (2) Patient-Acceptable-Symptom-Status (PASS 5), (3) EuroQol-Group-Questionnaire (EQ-5D-3L) and (4) Dimensions of Importance in Treatment of nAMD (DITAMD). Data were collected at baseline and after 3, 6 and 12 months of intravitreal antivascular endothelial growth factor treatment. Results were evaluated with t-tests and mixed linear regression analyses. RESULTS: The study included 197 patients. At baseline NEI-VFQ-25 (79.53±14.52) and EQ-5D (0.74±0.28) had relatively high scores, whereas PASS 5 was below 'acceptable' (3.30±0.80). At 12 months NEI-VFQ-25 and PASS 5 showed significant improvement, whereas EQ-5D and DITAMD remained unchanged. At baseline patients receiving treatment of the better-seeing eye (BSE) (n=52) reported significantly worse NEI-VFQ-25 and PASS 5 than patients for whom treatment only involved the worse-seeing eye (WSE), (n=145). In contrast to BSE patients, there was no improvement of NEI-VFQ-25 for WSE patients at 12 months, despite a significant improvement in best-corrected visual acuity (BCVA). Two independent variables, treatment including the BSE and BCVA for the treated eye, were found to predict both NEI-VFQ-25 and PASS 5. CONCLUSION: After 12 months of nAMD treatment, there was a significant improvement in PASS 5 and NEI-VFQ-25, the latter depending on whether therapy included BSE. EQ-5D and DITAMD remained unaltered.

Repeated measures in rheumatoid arthritis reduced the required sample size in a two-armed clinical trial.

OBJECTIVES: To investigate whether repeated measures in patients with rheumatoid arthritis will reduce the between subject variation and if so, to determine the optimal number of measures to effectively reduce the number of participants required in controlled clinical trials. STUDY DESIGN AND SETTING: A prospective observational study. Thirty-eight rheumatoid arthritis patients with a stable disease reported level of joint pain, fatigue and patient global assessment of disease activity on VAS scales as well as the Rheumatoid Arthritis Disease Activity Index (RADAI) daily during a total of 42 days. RESULTS: In all measures, the variation within each individual was substantial over a 42-day period. By increasing the number of measurements from one to five, the standard deviation (SD) decreased from 5.5% (RADAI score) to 11% (Pain VAS) resulting in a reduction in the number of patients needed in a clinical trial from 11% to 22%, respectively. When we used from 6 to 42 individual measurements, the decrease continued but the reduction was of a smaller magnitude. CONCLUSION: The use of up to five repeated measurements per patient will decrease the number of patients required in a two armed clinical trial by as much as 22%.

Development and testing of a patient-derived questionnaire for treatment of neovascular age-related macular degeneration: dimensions of importance in treatment of neovascular age-related macular degeneration.

PURPOSE: Studies reporting on patient perspectives during treatment of neovascular age-related macular degeneration (nAMD) are limited. Thus, the aim of this study was to develop and test psychometric performance of a patient-derived questionnaire to capture important experiences during intravitreal treatment. METHODS: Patients (n = 44) with at least 3-month experience of intravitreal injection treatment for nAMD identified the dimensions of priority and also performed a weighting procedure to develop a score for comparison. The questionnaire comprised two versions: one focusing on the relative importance' of the dimensions and one on the experience of the 'management' during treatment. The questionnaire was then tested for psychometric performance in a longitudinal design in newly diagnosed patients at baseline (n = 197), after three (n = 184) and six (n = 150) months of treatment. RESULTS: Of the 15 included dimensions, the following were most frequently reported: 'receive treatment to preserve vision', 'information', 'waiting time', 'trust' and 'accommodating staff. The psychometric testing showed moderate reliability (intraclass correlation coefficient: 0.65-0.67) for the two versions and high level of face validity (8.3). The dimensions, 'preserving vision', 'early access to treatment', 'pain relief', 'information about the treatment/diagnosis' and 'visual aids' were consistently reported higher in 'importance' than in 'management', at both 3 and 6 months, indicating a potential for improvement in clinical practice for these dimensions. CONCLUSION: This study provides a brief patient-derived questionnaire, expressed with a score with good psychometric performance that can be used for monitoring during intravitreal injection treatment of nAMD patients.

The Impact of Age-Related Macular Degeneration on Quality of Life and Its Association With Demographic Data: Results From the NEI VFQ-25 Questionnaire in a Norwegian Population.

Objective: To describe vision-related quality of life (VRQoL) in a Norwegian population of patients with newly diagnosed neovascular age-related macular degeneration (nAMD), and to evaluate the association with demographic data of age, gender, and civil status (married, cohabitants/unmarried, not cohabitants). Method: The Norwegian version of the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) questionnaire was administered to 145 patients recently diagnosed with nAMD. We used descriptive statistics and bivariate analysis to determine the distribution of demographic parameters and a possible association between demographic parameters and NEI VFQ-25 scores. Spearman correlation was employed to analyze the NEI VFQ-25 items and subscales scores. Results: Mean (SD) VFQ-25 total score was 78.5 (14.7). The scores per subscales varied from 64.7 to 89.7. No significant difference was revealed between demographic parameters and the NEI VFQ-25 items, except for one item (being with others) when comparing paired and nonpaired participants. Conclusion: In a Norwegian population with newly diagnosed nAMD, VRQoL is reported at a high baseline level. This is an important information for the health care personnel when discussing expectations during treatment with the patient. Age, gender, and civil status did not affect VRQoL.

Associations Between Five Important Domains of Health and the Patient Acceptable Symptom State in Rheumatoid Arthritis and Psoriatic Arthritis: A Cross-Sectional Study of 977 Patients.

OBJECTIVE: To explore the link between a patient acceptable symptom state (PASS) and patient-perceived impact in rheumatoid arthritis (RA) and psoriatic arthritis (PsA). METHODS: This was a cross-sectional study of unselected patients with definite RA or PsA. Pain, functional capacity, fatigue, coping, and sleep disturbance were assessed using a numeric rating scale (0-10) and compared between patients in PASS or not (Cohen's effect sizes). The domains of health associated with PASS status were assessed by multivariate forward logistic regression, and PASS thresholds were determined using the 75th percentile method and receiver operating characteristic analyses. RESULTS: Among 977 patients (531 with RA, 446 with PsA), the mean ± SD age was 53.4 ± 13.2 years, mean ± SD disease duration was 11.2 ± 10.0 years, and 637 (65.8%) were women. In all, 595 patients (60.9%) were in PASS; they had lower symptom levels, and all domains of health except sleep disturbance discriminated clearly between patients in PASS or not (effect sizes 0.73-1.45 in RA and 0.82-1.52 in PsA). In multivariate analysis, less pain and better coping were predictive of being in PASS. Odds ratios were: RA pain 0.80 (95% confidence interval [95% CI] 0.67-0.96), PsA pain 0.63 (95% CI 0.52-0.75), RA coping 0.84 (95% CI 0.74-0.96), and PsA coping 0.83 (95% CI 0.71-0.97). The cutoffs of symptom intensity (range 0-10), corresponding to PASS for the 5 domains of health and the 2 diseases were similar, i.e., approximately 4-5. CONCLUSION: In RA and PsA, PASS was associated with the 5 domains of health analyzed, and in particular with less pain and better coping.

Determinants of Patient-Physician Discordance in Global Assessment in Psoriatic Arthritis: A Multicenter European Study.

OBJECTIVE: Patient-physician discordance in global assessment of disease activity concerns one-third of patients, but what does it reflect? We aimed to assess patient-physician discordance in psoriatic arthritis (PsA) and patient-reported domains of health (physical and psychological) associated with discordance. METHODS: We analyzed the PsAID (Psoriatic Arthritis Impact of Disease), a cross-sectional, multicenter European study of patients with PsA according to expert opinion. Patient global assessment (PGA) and physician global assessment (PhGA) were rated on a 0-10 numeric rating scale. Discordance was defined as the difference (PGA-PhGA) and as the absolute difference |PGA-PhGA| ≥3 points. Determinants of PGA-PhGA were assessed by a stepwise multivariate linear regression among 12 physical and psychological aspects of impact: pain, skin problems, fatigue, ability to work/leisure, functional incapacity, feeling of discomfort, sleep disturbance, anxiety/fear, coping, embarrassment/shame, social participation, and depressive affects. RESULTS: In 460 patients (mean ± SD age 50.6 ± 12.9 years, 52.2% female, mean ± SD disease duration 9.5 ± 9.5 years, mean ± SD Disease Activity Index for Psoriatic Arthritis score 30.8 ± 32.4, and 40.4% undergoing treatment with biologic agents), the mean ± SD PGA was higher than the mean PhGA, with a mean absolute difference of 1.9 ± 1.8 points. Discordance defined by |PGA-PhGA| ≥3 of 10 concerned 134 patients (29.1%), and 115 patients (85.8% of the patients with discordance) had PGA>PhGA. Higher fatigue (ß = 0.14), lower self-perceived coping (ß = 0.23), and impaired social participation (ß = 0.16) were independently associated with a higher difference (PGA-PhGA). CONCLUSION: Discordance concerned 29.1% of these patient/physician dyads, mainly by PGA>PhGA. Factors associated with discordance were psychological rather than physical domains of health. Discordance was more frequent in patients in remission, indicating more work is needed on the patient perspective regarding disease activity.

Fatigue in psoriatic arthritis - a cross-sectional study of 246 patients from 13 countries.

OBJECTIVES: Fatigue is an aspect of psoriatic arthritis (PsA), which is important to patients. The objective was to evaluate magnitude of fatigue in PsA patients and to assess factors that might explain high levels of fatigue. METHODS: This was an ancillary analysis of a cross-sectional study in 13 countries of unselected PsA patients who fulfilled the CASPAR criteria. Patient-perceived importance of fatigue was assessed through a priority exercise. Levels of fatigue were assessed by a numeric rating scale (range 0-10). Factors potentially associated with fatigue>5/10: i.e., demographic variables (age, gender, disease duration, education level) and disease related characteristics including joint counts, C-reactive protein, skin psoriasis, axial involvement, enthesitis, dactylitis, structural damage, were assessed by univariate, multivariate logistic and multiple linear regression. RESULTS: In all, 246 patients were analysed: mean±standard deviation age 51.2±13.0years, mean disease duration 9.9±10.1years, mean DAS28 3.5±1.3. Fatigue was ranked second in patient-perceived importance, after pain. Magnitude of fatigue was high: mean fatigue 5.0±3.0. Fatigue>5/10 was well explained (variance explained 73%) by skin psoriasis (odds ratio 4.67 [95% confidence interval 1.05; 20.72]), tender joints (1.30 [1.01; 1.68]) and lower education level (1.09 [1.02; 1.23]). In the multiple linear regression model, fatigue was explained by skin psoriasis, tender joints, enthesitis, female gender, education level. CONCLUSIONS: Fatigue is a priority for PsA patients. Fatigue levels were high in these patients and fatigue>5/10 was mainly associated with disease-related factors but also patient-related variables, indicating that the etiology of fatigue in PsA is multifactorial.