Use of EQ-5D-5L for Assessing Patient-Reported Outcomes in a National Register for Specialized Rehabilitation.

OBJECTIVE: To compare problems reported on EQ-5D-5L dimensions, index, and EQ visual analog scale (VAS) scores in patients receiving specialized rehabilitation in Norway with general population norms. DESIGN: Multicenter observational study. SETTING: Five specialist rehabilitation facilities participating in a national rehabilitation register between March 11, 2020, and April 20, 2022. PARTICIPANTS: 1167 inpatients admitted (N=1167), with a mean age of 56.1 (range, 18-91) years; 43% were female. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: EQ-5D-5L dimension, index, and EQ VAS scores. RESULTS: At admission, mean±SD EQ-5D-5L index scores were 0.48 (0.31) compared to 0.82 (0.19) for general population norms. EQ VAS scores were 51.29 (20.74) compared to 79.46 (17.53) for population norms. Together with those for the 5 dimensions, these differences were all statistically significant (P<.01). Compared to population norms, patients undergoing rehabilitation had more health states as assessed by the 5 dimensions (550 vs 156) and EQ VAS (98 vs 49). As hypothesized, EQ-5D-5L scores were associated with number of diagnoses, admission to/from secondary care, and help with completion. At discharge there were statistically significant improvements in all EQ-5D-5L scores that compare favorably with available estimates for minimal important differences. CONCLUSIONS: The large deviations in scores at admission and score changes at discharge lend support to EQ-5D-5L application in national quality measurement. Evidence for construct validity was found through associations with number of secondary diagnoses and help with completion.

Comparison of EQ-5D-3L and 5L versions following operative fixation of closed ankle fractures.

PURPOSE: To undertake the first testing and comparison of measurement properties for the EuroQol EQ-5D-3L and 5L in patients with ankle problems. METHODS: The cross-sectional postal survey of 959 patients aged ≥ 18 years, who underwent surgical treatment (ORIF) for unstable and closed ankle fractures in Eastern Norway. Both the EQ-5D-3L and 5L were included in a postal questionnaire in 2015, 3-6 years post surgery. Missing data, floor and ceiling effects, and response consistency were assessed. Tests of validity included comparisons with scores for the SF-36 and widely used ankle-specific instruments. The 5L version was assessed for test-retest reliability. RESULTS: There were 567 (59%) respondents; 501 completed both versions and 182 (61%) the 5L retest questionnaire. The 5L outperformed the 3L in tests of data quality and classification efficiency. Correlations with scores for other instruments largely met expectations, those for the 5L being slightly higher. All 5L scores had acceptable levels of reliability. For the 5L index, the smallest detectable differences for group and individual comparisons were 0.02 and 0.20, respectively. CONCLUSION: The 5L outperformed the 3L in terms of data quality, number of health states assessed and tests of validity. The 5L is recommended in research and other applications following surgery for ankle fracture but further testing including responsiveness to change is recommended at clinically relevant follow-up periods.

Norwegian population norms for the EQ-5D-5L: results from a general population survey.

PURPOSE: To provide the first Norwegian EQ-5D-5L and EQ VAS population norms for the adult general population. METHODS: Postal survey of a random sample of 12,790 Norwegians identified through the National Registry of the Norwegian Tax Administration. Norms, weighted for Norwegian general population characteristics, are shown for the five EQ-5D-5L dimensions, EQ-5D index, and EQ VAS scores for seven age categories, females, males, and education level. RESULTS: There were 3200 (25.9%) respondents to 12,263 correctly addressed questionnaires. The EQ-5D-5L dimensions, EQ VAS, and background questions were completed by 3120 (24.6%) respondents. The mean age (SD) was 50.9 (21.7) and range was 18-97 years. The youngest age group of 18-29 years and oldest of 80 years and over had the highest (n = 691) and lowest (n = 239) number of respondents, respectively. Compared to the general population, the respondents comprised a greater number of females, younger and older ages, and had a higher education level. 32% of respondents reported no health problems on the EQ-5D-5L. From the youngest to oldest age groups, there was a general decline in health as assessed by the EQ-5D-5L. The exception was for anxiety/depression, where the youngest age groups had the poorest health. Apart from self-care, women reported poorer health than men, as assessed by the EQ-5D-5L; EQ VAS scores were similar for men and women. Higher levels of health (EQ-5D index, EQ VAS scores) were found with increasing levels of education. CONCLUSION: The population norms will improve interpretation of EQ-5D-5L and EQ VAS scores in Norwegian applications including clinical practice, clinical and health services research, and national quality registers where EQ-5D-5L is the most widely used patient-reported instrument.

The Public and Patient Engagement Evaluation Tool: forward-backwards translation and cultural adaption to Norwegian.

BACKGROUND: Patient engagement is recommended for improving health care services, and to evaluate its organisation and impact appropriate, and rigorously evaluated outcome measures are needed. METHODS: Interviews (N = 12) were conducted to assess relevance of the Canadian Public and Patient Engagement Evaluation Tool (PPEET) in a Norwegian setting were performed. The tool was translated, back translated, and assessed following cognitive interviews (N = 13), according to the COSMIN checklist. Data quality was assessed in a cross-sectional survey of patient advisory board members from different rehabilitation institutions (N = 47). RESULTS: Interviews with patient board representatives confirmed the relevance of the PPEET Organisational questionnaire in a Norwegian setting and contributed five additional items. Translation and back translation of the original PPEET showed no major content differences. Differences in vocabulary and sentence structure were solved by discussion among the translators. Comments from cognitive interviews mainly related to the use of different synonyms, layout, and minor differences in semantic structure. Results of the cross-sectional survey support the data quality and construct validity of PPEET items, including 95 score comparisons where 76 (80%) were as hypothesized. CONCLUSIONS: The PPEET Organisational questionnaire has been thoroughly translated and tested, and the resulting Evalueringsverktøy for Brukermedvirkning (EBNOR) has adequate levels of comprehensibility and content validity. Further testing for measurement properties is recommended, but given these results, the EBNOR should be considered for assessing patient engagement in a Norwegian health care organisational context.

Evaluation of three patient reported outcome measures following operative fixation of closed ankle fractures.

BACKGROUND: Several patient reported outcome measures (PROMs) are available for assessing the outcomes of ankle fracture but few have been compared for recommended measurement properties. This study compares the measurement properties of the Lower Extremity Function Scale (LEFS), Olerud Molander Ankle Score (OMAS) and Self-Reported Foot and Ankle Score (SEFAS) following ankle surgery. METHODS: The retrospective cohort study included 959 patients aged 18 years and over who underwent surgical treatment (ORIF) for unstable and closed ankle fractures in SE Norway. The PROMs were included in a postal questionnaire sent to patients' homes in 2015, three years after surgery. Missing data, structural validity, internal consistency, test-retest reliability and validity were assessed. RESULTS: Confirmatory factor analysis results showed model fit for the SEFAS and a bi-dimensional LEFS with scales of easy and difficult items. The OMAS performed less satisfactorily. Cronbach's alpha and test-retest correlations ranged from 0.82 to 0.96 and 0.91 to 0.93 respectively. The smallest detectable differences for group and individual comparisons were 14.1 to 20.6 and 0.93 to 1.55; SEFAS performed best. As hypothesised, instrument scores were highly correlated and with those for the EQ-5D and SF-36 physical functioning. Mean imputation where half or more items are completed increased usable scores by 1.4-15.7% without affecting measurement properties. CONCLUSIONS: The three instruments largely performed satisfactorily in relation to important measurement properties but the LEFS had evidence for two dimensions relating to easier and more difficult aspects of function. Mean imputation where half or more items are completed increased the number of usable responses for all three instruments. The three instruments represent different approaches to measuring outcomes and their content should be considered carefully when choosing between them. The SEFAS is designed for a range of foot disorders including ankle fractures and has the best measurement properties in this population.

The impact of psychological factors on condition-specific, generic and individualized patient reported outcomes in low back pain.

BACKGROUND: An individualized patient reported outcome (PRO) has recently been recommended within LBP research, but no study has evaluated this instrument with commonly applied PROs. Moreover, the impact of psychological factors has mostly been assessed for disease-specific instruments. The objective of this study was to assess the predictive value of illness perceptions, pain catastrophizing and psychological distress on 12 month outcomes assessed by specific, generic and individualized PROs recommended in low back pain (LBP). METHODS: Secondary analysis of patients with sub-acute or chronic LBP recruited for a cluster randomized controlled trial in primary care who completed a self-administered questionnaire at baseline and 12 months. 12 month scores for the Roland Morris Disability Questionnaire (RMDQ), the EuroQol (EQ-5D), and the Patient Generated Index (PGI) were dependent variables in hierarchical regression analysis. Independent variables included baseline scores for the Brief Illness Perceptions Questionnaire (Brief IPQ), Hopkins Symptom Check List (HSCL-25), Pain Catastrophizing Scale (PCS), health/clinical and sociodemographic variables. RESULTS: Of the 216 eligible patients included, 203 patients responded to the baseline questionnaire and 150 (74%) responded at 12 months. The mean age was 38.3 (SD 10.2) years and 57.6% were female. The Brief IPQ showed a statistically significant variation in the 12-months score of all the PROs, explaining 2.5% in RMDQ, 7.9% in EQ-5D, and 3.6% in PGI. Most of the explained variation for EQ-5D scores related to illness perceptions. The PCS explained 3.7% of the RMDQ and 2.5% in the EQ-5D scores. The HSCL-25 did not make a significant contribution. CONCLUSION: Illness perceptions and pain catastrophizing were associated with 12-month outcomes as assessed by condition-specific, generic and individualized PROs. The Brief IPQ and PCS have relevance to applications in primary care that include interventions designed to enhance psychological aspects of health and where the contribution of such variables to outcomes is of interest. Further studies should assess whether the Brief IPQ perform similarly in LBP populations in other health care settings.

Validity of standard gamble utilities in patients referred for aortic valve replacement.

PURPOSE: Standard gamble (SG) is the preferred method of assessing preferences in situations with uncertainty and risk, which makes it relevant to patients considered for aortic valve replacement (AVR). The present study assesses SG preferences in patients with severe aortic stenosis (AS). METHODS: All patients >18 years old with severe AS referred for AVR to our institution were invited to enroll in the study. The SG was administered by a clinical research nurse. The SF-36, EQ-5D 3L, Hospital Anxiety and Depression Scale (HADS), and AS symptoms were administered by self-completed questionnaire. We hypothesized that SG utilities would have low-to-moderate correlations with physical and mental aspects of health based on our pathophysiological understanding of severe AS. No correlations were expected with echocardiographic measures of the aortic valve. RESULTS: The response rate for SG was 98 %. SG moderately correlated with physical aspects of SF-36 (PCS, role-physical, vitality), health transition, AS symptoms, and EQ-VAS (ρ S = 0.31-0.39, p < 0.001) and had low correlation with mental aspects of SF-36 and EQ-5D (ρ S = 0.17-0.28, p < 0.001). No correlation was found between SG and HADS, echocardiographic measures, age, gender, or education level (ρ S = 0.01-0.06). CONCLUSIONS: SG is an acceptable and feasible method of assessing preferences in patients with severe AS that has evidence for validity. The inclusion of uncertainty lends the SG face validity in this population as a direct approach to assessing preferences and basis for QALY calculations.

Evaluation of the stages of completion and scoring of the Patient Generated Index (PGI) in patients with rheumatic diseases.

PURPOSE: To evaluate the stages of completion and approaches to scoring the PGI for reliability, validity and responsiveness. METHODS: Participants of inpatient rehabilitation or self-management programmes completed the closed PGI with the same areas at 1 year as baseline. Test-retest reliability, validity and responsiveness were assessed for area scores (stage one), points (stage two) and methods of scoring the PGI. RESULTS: One hundred and forty-five patients participated, and 118 (81 %) completed the PGI correctly. Test-retest intraclass correlations were over 0.90 for area scores (stage two) and were 0.87 and 0.86 for final PGI scores with and without the sixth "rest of life" box. Individual area scores had the highest correlations with those for instruments assessing similar constructs; those for the area "rest of life" were lower. Compared to scores based on the sum of the stage two areas, PGI scores had higher correlations of a moderate level with those for patient-reported instruments widely used within rheumatology. Correlations were of a similar level with and without the sixth "rest of life" area, and those based on baseline points at follow-up were highest. The PGI had higher SRMs than the other instruments at 1 year, the highest being for PGI scores based on baseline points. CONCLUSIONS: The fully closed version of the PGI, which uses baseline areas and baseline stage three points at follow-up, is most appropriate for assessing outcomes within healthcare evaluation. The sixth "rest of life" area has poorer measurement properties, and its removal does not adversely affect the measurement properties of the PGI.

Measurement properties of instruments assessing self-efficacy in patients with rheumatic diseases.

The measurement properties of instruments assessing self-efficacy (SE) in patients with rheumatic diseases were reviewed. The consensus-based standards for the selection of health measurement instruments (COSMIN) checklist was applied following systematic searches of seven electronic databases from 1989 to December 2011. Fifteen articles met the inclusion criteria that included the arthritis SE scales (ASES), generalized SE scale (GSES), joint protection SE scale (JP-SES), Marcus & Resnick SE exercise behaviour (SEEB) instruments, and RA SE scale (RASE). The ASES and RASE have undergone more than one evaluation. There was little formal evaluation of content validity for the instruments. Evidence for the RASE suggests that it is not unidimensional. The JP-SES and SEEB were evaluated using modern psychometric methods. The instruments require further evaluation before application. The quality of the evidence for the ASES and RASE is generally poor. The generic focus of the GSES limits its relevance. The JP-SES and SEEB have only undergone one evaluation and that relating to the latter was narrow in scope. Future studies should address these methodological weaknesses.

Patient-reported function, quality of life and prosthesis wear in adults born with one hand: a national cohort study.

We invited individuals aged above 16 years with a congenital transverse reduction deficiency at and above the wrist born in Norway between 1970 and 2006 to complete the short version of the Disabilities of the Arm, Shoulder and Hand Outcome Measure, the 5-Level EuroQoL-5-Dimension instrument, the RAND 36-Item Short Form Health Survey and a single-item questionnaire on arm function, appearance, pain and prosthesis wear. Of 154 eligible participants, 58 (38%) responded. Their scores were not different from the general population. All had been offered prostheses, and 56 (97%) had been fitted at a median age of 1 year (interquartile range 0-2.8). Of the participants, 37 (64%) were still prosthesis wearers, while 21 (36%) were non-wearers or using gripping devices only. Prosthesis wearers had higher levels of 'vitality' as assessed by the RAND-36 and rated their arm appearance higher, but there were no other score differences, indicating that prosthesis rejection is not associated with worse functional outcomes.Level of evidence: III.

How do survivors after out-of-hospital cardiac arrest perceive their health compared to the norm population? A nationwide registry study from Norway.

Introduction: Self-perceived health status data is usually collected using patient-reported outcome measures. Information from the patients' perspective is one of the important components in planning person-centred care. The study aimed to compare EQ-5D-5L in survivors after out-of-hospital cardiac arrest (OHCA) with data for Norwegian population controls. Secondary aim included comparing characteristics of respondents and non-respondents from the OHCA population. Methods: In this cross-sectional survey, 714 OHCA survivors received an electronic EQ-5D-5L questionnaire 3-6 months following OHCA. EQ-5D-5L assesses for five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five-point descriptive scales and overall health on a visual analogue scale from 0 (worst) to 100 (best) (EQ VAS). Results are used to calculate the EQ index ranging from -0.59 (worst) to 1 (best). Patient responses were matched for age and sex with existing data from controls, collected through a postal survey (response rate 26%), and compared with Chi-square tests or t-tests as appropriate. Results: Of 784 OHCA survivors, 714 received the EQ-5D-5L, and 445 (62%) responded. Respondents had higher rates of shockable first rhythm and better cerebral performance category scores than the non-respondents. OHCA survivors reported poorer health compared to controls as assessed by EQ-5D-5L dimensions, the EQ index (0.76 ± 0.24 vs 0.82 ± 0.18), and EQ VAS (69 ± 21 vs 79 ± 17), except for the pain/discomfort dimension. Conclusions: Norwegian OHCA survivors reported poorer health than the general population as assessed by the EQ-5D-5L. PROMs use in this population can be used to inform follow-up and health care delivery.

Psychometric properties of the Norwegian version of the patient generated index in patients with rheumatic diseases participating in rehabilitation or self-management programmes.

OBJECTIVE: In rehabilitation, treatment is individually tailored to each patient's goals. Individualized instruments allow patients to choose domains that they consider important, which may make them particularly appropriate as evaluative tools in this setting. We aimed to evaluate the psychometric properties of the Norwegian version of the patient generated index (PGI) in patients with rheumatic diseases participating in inpatient rehabilitation or self-management programmes. METHODS: Patients completed the PGI together with other outcome measures at arrival and 5 and 52 weeks after arrival. The PGI was assessed for data quality by completion rates, reliability by the intraclass correlation coefficient (ICC), agreement by standard error of measurement (SEM) and smallest detectable change (SDC). Construct validity was assessed by testing a priori hypotheses regarding correlation between PGI scores and other outcome measures. Responsiveness was assessed by an a priori hypothesis regarding the correlation of different change scores and standardized response means (SRMs). RESULTS: A total of 145 patients participated and 118 (81%) completed the PGI correctly. The ICC was 0.87, SEM 7.25 and SDC 20.10. Ninety-three per cent of the hypotheses of correlation were confirmed in tests for construct validity. Responsiveness was confirmed in 53% and 71% of hypotheses tested at 5 and 52 weeks. SRMs were 0.2 and 0.4, respectively. CONCLUSION: The results support the validity, reliability and responsiveness of the Norwegian version of the PGI in patients with rheumatic diseases and its application as an outcome measure in rehabilitation or self-management programmes. Further research is needed to improve completion rates for the PGI.

Comparative responsiveness and minimal change of the Knee Quality of Life 26-item (KQoL-26) questionnaire.

OBJECTIVES: To assess the responsiveness of the KQoL-26 and demonstrate minimal change for this instrument in two different samples of patients with suspected internal derangement of the knee. METHODS: Data were collected from two surveys conducted alongside a clinical trial: the arthroscopy sample and the general practitioner (GP) sample. The effect size (ES) was used to assess responsiveness. Anchor-based minimal change included minimal clinical important difference (MCID) and receiver operator characteristic curves; standardized error of measurement and minimal detectable change (MDC) was employed for distribution-based approaches. The KQoL-26 results are compared with those for the Lysholm Knee Score, EQ-5D and SF-36. RESULTS: The arthroscopy sample consisted of 121 participants and the GP sample of 218 participants at baseline. The largest ES was found for the KQoL-26 emotional functioning scale in both samples. The results were in favour of the condition-specific instrument. The MCID for KQoL-26 physical functioning, activities limitations and emotional functioning scales were 3, 15 and 18, respectively, in the arthroscopy sample; they were 11, 16 and 24 in the GP sample. The MDC 95 % was estimated as 18, 28 and 34, and 15, 24 and 30 in each sample, respectively. CONCLUSIONS: The KQoL-26 emotional functional scale was the most responsive of all scales. It is recommended that an instrument such as the KQoL-26 that includes emotional functioning should be included rather than the Lysholm in future clinical trials of patients with suspected internal derangement of the knee.

Parent experiences of inpatient pediatric care in relation to health care delivery and sociodemographic characteristics: results of a Norwegian national survey.

BACKGROUND: The national survey of parent experiences with inpatient pediatric care contribute to the Norwegian system of health care quality indicators. This article reports on the statistical association between parent experiences of inpatient pediatric care and aspects of health care delivery, child health status and health outcome as assessed by the parents, and the parents' sociodemographic characteristics. METHODS: 6,160 parents of children who were inpatients at one of Norway's 20 pediatric departments in 2005 were contacted to take part in a survey that included the Parent Experience of Pediatric Care questionnaire. It includes 25 items that form six scales measuring parent experiences: doctor services, hospital facilities, information discharge, information about examinations and tests, nursing services and organization. The six scales were analyzed using OLS-regression. RESULTS: 3,308 (53.8%) responded. Mean scores ranged from 62.81 (organization) to 72.80 (hospital facilities) on a 0-100 scale where 100 is the best possible experience. Disappointment with staff, unexpected waiting, information regarding new medication, whether the staff were successful in easing the child's pain, incorrect treatment and number of previous admissions had a statistically significant association with at least five of the PEPC scale scores. Disappointment with staff had the strongest association. Most sociodemographic characteristics had weak or no associations with parent experiences. CONCLUSIONS: The complete relief of the child's pain, reducing unexpected waiting and disappointment with staff, and providing good information about new medication are aspects of health care that should be considered in initiatives designed to improve parent experiences. In the Norwegian context parent experiences vary little by parents' sociodemographic characteristics.

Illness perceptions in patients receiving rheumatology rehabilitation: association with health and outcomes at 12 months.

BACKGROUND: Illness perceptions have been found to change over time and following health care. Hence, addressing illness perceptions alongside existing health care interventions may be important for the sustainment of health gains following rehabilitation. The aim of this study was to measure the illness perceptions of patients receiving inpatient rheumatology rehabilitation and assess the association with aspects of health and outcomes at baseline, discharge and 12 months. METHODS: Patients with a rehabilitation stay of one week or more at three institutions in Norway in 2009 were invited to participate in the study. At baseline, discharge and 12 months, patients completed The Rheumatic Disease Illness Perception Questionnaire (RD-IPQ) which includes aspects of illness perceptions important to patients with rheumatic diseases. Stepwise regression analysis was used to assess associations between RD-IPQ scores and different aspects of health at baseline and follow-up after controlling for other aspects of health and sociodemographic variables. RESULTS: For the 134 patients included in the study, baseline RD-IPQ scores had a mean of 58.2 (SD 14.9) on a 0-100 scale, where 100 is the worst possible. Scores showed improvement after the rehabilitation stay which were maintained at 12 months. RD-IPQ scores were positively associated with health and outcomes. At baseline RD-IPQ scores were statistically significant in explaining variation in pain, physical function and SF-36 mental health scores. Baseline RD-IPQ scores were significant in explaining fatigue, pain, SF-36 role limitations and social function scores following rehabilitation and at 12 months. CONCLUSION: Illness perceptions as measured by the RD-IPQ were associated with health and outcomes as measured by rheumatology-specific and generic instruments. The consideration of illness perceptions as a component of rehabilitation may be important in achieving desired outcomes.

Health-related quality of life in young Norwegian survivors of out-of-hospital cardiac arrest related to pre-arrest exercise habits.

Aim: To compare health-related quality of life (HRQoL) in young survivors of out-of-hospital cardiac arrest (OHCA) in Norway with an age and sex-matched reference population and to assess the associations between exercise volume prior to OHCA and HRQoL after. Methods: We present data from survivors aged 18-50 years registered with OHCA in the Norwegian Cardiac Arrest Registry between January 1st 2015 and December 31st 2017. Survivors were invited to answer two questionnaires; (1) the Short Form 36 (SF-36) Health Survey Version 1, and (2) about exercise habits prior to OHCA. Respondents were randomly matched 1:1 for age and sex with a reference population (data were available from the Norwegian Centre for Research Data). Results: Of the 175 survivors invited, 95 (54%) responded, median age was 44 (range 35-48) years, 26 (27%) females. Valid results for SF-36 were available for 91 survivors, of whom 87 reported pre-OHCA exercise-volume. Prior to OHCA, 21 did no regular exercise, 44 exercised 1-4 hours/week and 22 exercised ≥5 hours/week. Compared to the reference population survivors had significantly (p < 0.01) poorer SF-36 scores for scales relating to physical- and mental health. SF-36 scale scores were similar in survivors who did and did not exercise regularly. Within the regular exercisers, survivors reporting ≥5 hours of exercise/week had better SF-36 scores than those exercising less. Conclusion: Poorer HRQoL in survivors compared to the reference population should prompt us to explore how treatment and rehabilitation could be improved and adapted. More exercise before OHCA favoured better HRQoL after, which aligns well with the recognised positive association between HRQoL and physical activity in general.

Evaluation of Ankylosing Spondylitis Quality of Life questionnaire: responsiveness of a new patient-reported outcome measure.

OBJECTIVE: To determine the responsiveness and minimal important change (MIC) of Evaluation of Ankylosing Spondylitis Quality of Life (EASi-QoL), a reliable and valid patient-reported measure of AS-specific quality of life with four domains: physical function (PF), disease activity (DA), emotional well-being (EWB) and social participation (SP). METHODS: A total of 1000 UK AS patients received a postal questionnaire including EASi-QoL. Comparative responsiveness of EASi-QoL was assessed against measures reflecting similar health domains in patients self-reporting an improvement in their AS-specific health at 6 months on a health transition question. Effect size (ES) statistics were calculated for all measures and MIC was determined for EASi-QoL. Comparative responsiveness was determined in a randomized trial of AS patients receiving etanercept (ETN) 50 mg weekly or SSZ 3 g daily. RESULTS: Of 470 patients, 80 responding at 6 months reported health improvement. Responsiveness (ES) for EASi-QoL domains was superior or similar to comparator measures: DA 0.72 vs BASDAI 0.58; SP 0.52 vs SF-36 social functioning 0.29; PF 0.32 vs BASFI 0.28 and SF-36 PF 0.24; EWB 0.40 vs HADS-anxiety 0.13, HADS-depression 0.21 and SF-36 mental health 0.35. ES for the ASQoL was 0.40. Superior ES was seen in those improving somewhat. In the randomized trial, all EASi-QoL domains had superior responsiveness to comparator measures following ETN treatment. Following SSZ treatment, all EASi-QoL domains were highly responsive, but BASDAI and BASFI was more responsive than EASi-QoL(DA) and (PF), respectively. CONCLUSION: In patients reporting improvement during routine clinical practice or following treatment with ETN or SSZ, EASi-QoL domains have superior or comparable responsiveness than comparable measures.

Evaluation of the Norwegian version of the Dyspnoea-12 questionnaire in patients with COPD.

BACKGROUND: The Dyspnoea-12 (D-12) questionnaire is widely used and tested in patients with breathing difficulties. The objective of this study was to translate and undertake the first evaluation of the measurement properties of the Norwegian version of the D-12 in patients with chronic obstructive pulmonary disease (COPD) attending a 4-week inpatient pulmonary rehabilitation programme. METHODS: Confirmatory factor analysis was used to assess structural validity. Fit to the Rasch partial credit model and differential item functioning (DIF) were assessed in relation to age, sex and comorbidity. Based on a priori hypotheses, validity was assessed through comparisons with scores for the COPD Assessment Test (CAT), Hospital Anxiety and Depression Scales (HADS) and clinical variables. RESULTS: There were 203 (86%) respondents with a mean age (SD) of 65.2 (9.0) years, and 49% were female. The D-12 showed satisfactory structural validity including presence of physical and affective domains. There was acceptable fit to Rasch model including unidimensionality for the two domains, and no evidence of DIF. Correlations with scores for the CAT, HADS and clinical variables were as hypothesised and highest for domains assessing similar aspects of health. CONCLUSIONS: The Norwegian version of the D-12 showed good evidence for validity and internal consistency in this group of patients with COPD, including support for two separate domains. Further testing for these measurement properties is recommended in other Norwegian patients with dyspnoea.

The Norwegian EUROPEP questionnaire for patient evaluation of general practice: data quality, reliability and construct validity.

BACKGROUND: The EUROPEP is a widely used international instrument to evaluate general practice care from the perspective of patients, but measurement properties including reliability at the GP level are not sufficiently documented. OBJECTIVE: The objectives of this study were to assess the psychometric properties of the Norwegian version of the EUROPEP and estimate GP-level reliability for scales and items. METHODS: Nine hundred patients consulting nine GPs at a medical centre in Norway were invited to complete the Norwegian EUROPEP at home following a recent consultation. We assessed item missing and ceiling effects and used factor analysis to assess the structure of the 23 items of the EUROPEP. Scales were tested for reliability and construct validity, while reliability at the GP level was tested for items and scales. RESULTS: Five hundred and fifty-seven patients (61.9%) returned the questionnaire. Seven of 23 items had missing responses >10% and 20% had high ceiling effects. Factor analysis identified two groups of questions that formed scales with satisfactory internal consistency reliability and validity. The clinical behaviour scale (12 items) and the organization of care scale (4 items) met the criterion of 0.7 for Cronbach's alpha. The GP-level reliability was >0.7 for both scales, but 9 of 23 items were below the criterion of 0.7. CONCLUSIONS: The study identified two scales in the Norwegian EUROPEP instrument with satisfactory psychometric properties. However, high proportions of item non-response large ceiling effects and low GP-level reliability for several items indicate the need for further instrument refinement.

Identification of shoulder-specific patient acceptable symptom state in patients with rheumatic diseases undergoing shoulder surgery.

STUDY DESIGN: Clinical measurement study with a longitudinal design. OBJECTIVE: Estimate Patient Acceptable Symptom State (PASS) thresholds in six shoulder outcome measures and two pain scales. METHODS: Patients with rheumatic diseases undergoing shoulder surgery were assessed at baseline and one-year follow-up (with Bostrom Shoulder Movement Impairment Scale, Constant, Disability of the Arm, Shoulder and Hand [DASH], Oxford Shoulder Score [Oxford], Shoulder Function Assessment Scale, Shoulder Pain and Disability Index [Spadi], and two visual analog pain scales [VAS]). PASS thresholds were estimated using the 75th percentile and the receiver operating characteristic curve approach. RESULTS: One hundred patients were included; 74 (74%) patients considered their shoulder function to be acceptable (PASS+), which was significantly associated with being female, odds ratio (OR) 4.54, and having better functional status (Health Assessment Questionnaire), OR 0.17 (p<0.05). Activity-related pain (VAS), the Oxford, and the Spadi showed best discriminative accuracy for PASS. All measures estimated changes exceeding the minimal clinical important difference. CONCLUSION: The Oxford and the Spadi showed better discriminant ability for PASS than the more commonly used Constant score and the DASH. The PASS thresholds for pain showed that patients accepted less pain at rest than during activity, underlining the importance of assessing both aspects of pain. LEVEL OF EVIDENCE: 3. Diagnostic study.