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.

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.

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.

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.

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 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.

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 Norwegian PROMIS-29: psychometric validation in the general population for Norway.

BACKGROUND: The Patient Reported Outcome Measurement Information System profile instruments include "high information" items drawn from large item banks following the application of modern psychometric criteria. The shortest adult profile, PROMIS-29, looks set to replace existing short-form instruments in research and clinical practice. The objective of this study was to undertake the first psychometric evaluation of the Norwegian PROMIS-29, following a postal survey of a random sample of 12,790 Norwegians identified through the National Registry of the Norwegian Tax Administration. 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, gender, and education. PROMIS-29 scores were compared to those for the EQ-5D-5L and the Self-assessed Comorbidity Questionnaire (SCQ), for purposes of assessing validity based on a priori hypotheses. RESULTS: There were 3200 (25.9%) respondents with a mean age (SD) of 51 (20.7, range 18 to 97 years) and 55% were female. The PROMIS-29 showed satisfactory structural validity and acceptable fit to Rasch model including unidimensionality, and measurement invariance across age and education levels. One pain interference item had uniform DIF for gender but splitting gave satisfactory fit. Domain reliability estimates ranged from 0.85 to 0.95. Correlations between PROMIS-29 domain, SCQ and EQ-5D scores were largely as expected, the largest being for scores assessing very similar aspects of health. CONCLUSIONS: The Norwegian version of the PROMIS-29 is a reliable and valid generic self-reported measure of health in the Norwegian general population. The instrument is recommended for further application, but the analysis should be replicated and responsiveness to change assessed in future studies before it can be recommended for clinical and health services evaluation in Norway.

Elicitation of Norwegian EQ-5D-5L values for hypothetical and experience-based health states based on the EuroQol Valuation Technology (EQ-VT) protocol.

INTRODUCTION: Norway is one of several European countries that lacks a national value set and scoring algorithm for the EuroQol five dimensions (EQ-5D). Recent studies have found differences between countries in terms of health values or preferences for health states described by instruments such as the EQ-5D. The project aims to model a national value set for the five level version of the EQ-5D based on values elicited from a representative sample of the Norwegian adult general population in terms of region, age, sex and level of education. Using a sampling strategy supporting the collection of values for both hypothetical and experienced health states, the study will have the additional aim of assessing the feasibility of collecting experience-based values in accordance with the latest EQ-5D valuation study protocol, and comparing values with those given for hypothetical health states. METHODS AND ANALYSIS: Multistage random sampling and quota-sampling will contribute to representativeness. To increase the number of valuations of experienced health states, those with less than perfect health will be oversampled, increasing the total number of interviews from 1000 to 1300-1500. The most recent EQ-5D valuation protocol will be followed which includes computer assisted face-to-face, one-to-one interviews and use of composite time trade-off and discrete choice experiments. ETHICS AND DISSEMINATION: The study has been reviewed and found to be outside of the scope of the ethics committee and thus not in need of ethical approval. The study findings will be disseminated through peer-reviewed publications, conference presentations and summaries for key stakeholders and partners in the field. The scoring algorithms will be available for widely used statistical software.

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.

Patient-reported outcomes after referral for possible valve replacement in patients with severe aortic stenosis.

OBJECTIVES: Health-related quality of life (HRQoL) is an important outcome after surgical aortic valve replacement (SAVR). To improve interpretation of HRQoL, mean score change and change in terms of minimal important difference (MID) were assessed using validated instruments for measuring patient-reported outcomes in patients with severe aortic stenosis referred for possible SAVR. METHODS: Of the 442 included patients with severe aortic stenosis evaluated for possible SAVR, 351 were referred to SAVR (operated) and 91 to medical treatment (unoperated). At presurgical evaluation and 1 year postoperatively, HRQoL was assessed using SF-36v2 and EQ-5D. Results were compared with outcomes reported in unoperated patients. We explored the association of clinical factors and improvements corresponding to MID. RESULTS: Among the operated patients, statistically significant change was found for EQ-5D scores and SF-36 scale scores for physical functioning, role-physical, bodily pain, general health, vitality and physical summary score. The largest proportion of operated patients achieving change corresponding to at least MID was 61.5% for physical summary score. Change in unoperated patients also related largely to physical scales of the SF-36. However, smaller proportions of unoperated patients reported improvements, and larger proportions reported decline reaching MID. Baseline scores, but no clinical covariates, were consistently associated with improved HRQoL reaching MID across instruments for those referred to SAVR. CONCLUSIONS: This study found improvement in HRQoL 1 year after SAVR for patients with severe aortic stenosis. Results in unoperated patients suggest that HRQoL deteriorates 1 year after evaluation of possible SAVR. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov (NCT01794832).

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.

The Universal Patient Centeredness Questionnaire: scaling approaches to reduce positive skew.

PURPOSE: Surveys of patients' experiences typically show results that are indicative of positive experiences. Unbalanced response scales have reduced positive skew for responses to items within the Universal Patient Centeredness Questionnaire (UPC-Q). The objective of this study was to compare the unbalanced response scale with another unbalanced approach to scaling to assess whether the positive skew might be further reduced. PATIENTS AND METHODS: The UPC-Q was included in a patient experience survey conducted at the ward level at six hospitals in Norway in 2015. The postal survey included two reminders to nonrespondents. For patients in the first month of inclusion, UPC-Q items had standard scaling: poor, fairly good, good, very good, and excellent. For patients in the second month, the scaling was more positive: poor, good, very good, exceptionally good, and excellent. The effect of scaling on UPC-Q scores was tested with independent samples t-tests and multilevel linear regression analysis, the latter controlling for the hierarchical structure of data and known predictors of patient-reported experiences. RESULTS: The response rate was 54.6% (n=4,970). Significantly lower scores were found for all items of the more positively worded scale: UPC-Q total score difference was 7.9 (P<0.001), on a scale from 0 to 100 where 100 is the best possible score. Differences between the four items of the UPC-Q ranged from 7.1 (P<0.001) to 10.4 (P<0.001). Multivariate multilevel regression analysis confirmed the difference between the response groups, after controlling for other background variables; UPC-Q total score difference estimate was 8.3 (P<0.001). CONCLUSION: The more positively worded scaling significantly lowered the mean scores, potentially increasing the sensitivity of the UPC-Q to identify differences over time and between providers. However, none of the groups exhibited large positive skew and ceiling effects, implying that such effects might not be a big measurement problem for either scaling format. We recommend using the standard scaling in surveys producing external indicators for inter-provider comparisons. The more positively worded scaling has greater relevance for local measurement work where the results of patient experience surveys have shown large positive skew, and intra-provider comparison is the primary goal.

The Universal Patient Centeredness Questionnaire: reliability and validity of a one-page questionnaire following surveys in three patient populations.

BACKGROUND: This study developed and tested the reliability and validity of the Universal Patient Centeredness Questionnaire (UPC-Q). METHODS: The UPC-Q developed in this study has three parts: 1) the aspects that patients consider the most important when receiving a relevant health care service, rating the health care services on these aspects and their prioritization, 2) the overall experiences of patients using the relevant health care service, and 3) suggestions for improvements. The UPC-Q was tested in four different patient-experience surveys in 2015, including psychiatric inpatients (n=109), general practitioner (GP) patients (n=1,059), and inpatients from two hospital samples (n=973, n=599). The UPC-Q was tested for item completeness and ceiling effects, while the UPC-Q scale consisting of the first part of the UPC-Q was tested for internal consistency reliability and construct validity. RESULTS: The percentage of patients rating at least one aspect was 70.6% for psychiatric inpatients, 77.6% for hospital inpatients, and 90.6% for GP patients, while 88.9% of the psychiatric inpatients, 93.1% of the hospital inpatients, and 95.3% of the GP patients were able to prioritize the aspects. The internal consistency reliability of the UPC-Q scale was acceptable in all samples (Cronbach's alpha >0.7), and construct validity was supported by 20 of 21 significant associations between the UPC-Q and related variables. The UPC-Q total score was skewed toward positive evaluations, but the ceiling effect was smaller for an unbalanced response scale than for a balanced scale. CONCLUSION: The UPC-Q includes ratings of what is most important for individual patients, while at the same time providing data for improving the quality of health care and making it possible to monitor trends within and across patient populations. This study included psychiatric inpatients, hospital inpatients, and GP patients, and found that the UPC-Q performed well in terms of acceptance, internal consistency reliability, and construct validity.

Eliciting Patient Risk Willingness in Clinical Consultations as a Means of Improving Decision-Making of Aortic Valve Replacement.

BACKGROUND: Treatment decisions for aortic valve replacement (AVR) should be sensitive to patient preferences. However, we lack knowledge of patient preferences and how to obtain them. METHODS AND RESULTS: We assessed the mortality risk patients were willing to accept when undergoing AVR by using the Standard Gamble method and aimed to show how this risk willingness was affected by level of disease burden. We report findings from 439 patients, aged >18 years with severe aortic stenosis who were referred for evaluation of AVR to our institution. The vast majority of patients accepted a mortality risk regarded as high or prohibitive according to current guidelines. Of the 439 patients, 51% patients were willing to forego surgery with high mortality risk (8-50%) and 19% were willing accept a prohibitive mortality risk (>50%) as defined in current guidelines. However, the risk willingness varied considerably. Acceptance of prohibitive risk willingness (>50%) was associated with reporting of 3 to 5 different restricting symptoms, with an odds ratio of 4.07 (95% CI 1.56-10.59) opposed by increasing score on EuroQol-Visual Analog Scale, with an odds ratio of 0.99 (95% CI 0.97-1.00). The poor ability to predict risk willingness based on available clinical variables and health status suggests that other factors may be important advocating the need for tools for soliciting patient's preferences individually. CONCLUSION: When undergoing AVR, patients were willing to accept considerably higher perioperative risk than what is considered acceptable in current guidelines and practice. Patient preferences varied considerably, and they should be directly assessed and taken into account in decision-making and guidelines. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/. Unique identifier: NCT01794832.

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.

Individualized quality of life in patients with low back pain: reliability and validity of the Patient Generated Index.

OBJECTIVE: To evaluate the reliability and validity of the improved version of the Patient Generated Index (PGI) in patients with low back pain. METHODS: The PGI was administered to 90 patients attending care in 1 of 6 institutions in Norway and evaluated for reliability and validity. The questionnaire was given out to 61 patients for re-test purposes. RESULTS: The PGI was completed correctly by 80 (88.9%) patients and, of the 61 patients responding to the re-test, 50 (82.0%) completed both surveys correctly. PGI scores were approximately normally distributed, with a median of 40 (range 80), where 100 is the best possible quality of life. There were no floor or ceiling effects. The 5 most frequently listed areas affecting quality of life were pain, sleep, stiffness, socializing and housework. The test-retest intraclass correlation coefficient was 0.73. The smallest detectable changes for individual and group purposes were 32.8 and 4.6, respectively. The correlations between PGI scores and other instrument scores followed a priori hypotheses of low to moderate correlations. DISCUSSION: The PGI has evidence for reliability and validity in Norwegian patients with low back pain at the group level and may be considered for application in intervention studies when a comprehensive evaluation of quality of life is important. However, the smallest detectable change, of approximately 30 points, may be considered too large for individual purposes in clinical applications.