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.

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.

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.

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.

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.

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.

Rasch analysis of the Psychiatric Out-Patient Experiences Questionnaire (POPEQ).

BACKGROUND: The Psychiatric Out-Patient Experiences Questionnaire (POPEQ) is an 11-item core measure of psychiatric out-patients experiences of the perceived outcome of the treatment, the quality of interaction with the clinician, and the quality of information provision. The POPEQ was found to have evidence for reliability and validity following the application of classical test theory but has not previously been assessed by Rasch analysis. METHODS: Two national postal surveys of psychiatric outpatients took place in Norway in 2004 and 2007. The performance of the POPEQ, including item functioning and differential item functioning, was assessed by Rasch analysis. Principal component analysis of item residuals was used to assess the presence of subdimensions. RESULTS: 6,677 (43.3%) and 11,085 (35.2%) psychiatric out patients responded to the questionnaire in 2004 and 2007, respectively. All items in the scale were retained after the Rasch analysis. The resulting scale had reasonably good fit to the Rasch model. The items performed the same for the two survey years and there was no differential item functioning relating to patient characteristics. Principal component analysis of the residuals confirmed that the measure to a high degree is unidimensional. However, the data also reflects three potential subscales, each relating to one of the three included aspects of health care. CONCLUSIONS: The POPEQ had excellent psychometric properties and Rasch analysis further supported the construct validity of the scale by also identifying the three subdimensions originally included as components in the instrument development. The 11-item instrument is recommended in future research on psychiatric out-patient experiences. Future development may lead to the construction of more precise measures of the three subdomains that the POPEQ is based on.

The Patient Experiences Questionnaire for Out-of-Hours Care (PEQ-OHC): data quality, reliability, and validity.

OBJECTIVE: To develop and evaluate the Patient Experiences Questionnaire for Out-of-Hours Care (PEQ-OHC) in Norway. DESIGN: Questionnaire development was based on a systematic literature review of existing questionnaires, interviews with users, and expert group consultation. Questionnaire testing followed a postal survey of users who had attended out-of-hours centres in the North, West, and South of Norway. SETTING: Primary care out-of-hours services. SUBJECTS: The questionnaire was pre-tested with 13 users and was then mailed to 542 users who had had telephone contact and/or had a consultation with one of three out-of-hours centres. MAIN OUTCOME MEASURES: Data quality, internal consistency, reliability, and construct validity. RESULTS: The questionnaire was considered to have good content validity by the expert group. There were 225 (41.51%) respondents to the postal questionnaire. Levels of missing data at the item and scale level were acceptable. Principal component analysis supported the four scales of user experiences relating to telephone contact, doctor services, nursing services, and organization. Item-total correlations were all above 0.5 and Cronbach's alpha was above 0.80 for all scales. Statistically significant associations based on explicit hypotheses were evidence for the construct validity of the PEQ-OHC. CONCLUSION: The development of the PEQ-OHC followed a rigorous process based on a systematic review, interviews with users, and an expert group which lend the questionnaire content validity. The PEQ-OHC has evidence for data quality, internal consistency, reliability, and construct validity.

Ankylosing spondylitis and its impact on sexual relationships.

OBJECTIVE: To explore the impact of AS on the sexual relationships of a large cohort of patients, across the UK. METHODS: A total of 1000 patients with a confirmed diagnosis of AS under the clinical care of 10 specialist rheumatology centres across the UK were invited to participate in a study evaluating a new quality of life measure. Patients completed a questionnaire, which also included questions relating to the impact of AS on their sexual relationships, sociodemographic and clinical characteristics. RESULTS: Six hundred and twelve (64%) patients took part in the study. The majority were male (71.6%), mean age 50.8 +/- 12.2 years, mean diagnosed disease duration 17.3 +/- 11.7 years and mean symptom duration 23 +/- 18.6 years. Of those who responded to the question on sexual relationships (n = 552), 210 (38.0%) reported that their sexual relationships were affected 'moderately', 'quite a bit' or 'extremely' by their AS. Males reported greater sexual problems with increasing age. Poor function [odds ratio (OR) 3.64; 95% CI 1.92, 6.87], depression (OR 2.03; 95% CI 1.21, 3.41), greater disease activity (OR 2.10; 95% CI 1.01, 4.40), unemployment (OR 1.99; 95% CI 1.16, 3.40) and poor self-efficacy (OR 1.25; 95% CI 1.09, 1.43) were independently associated with a greater impact on patients' sexual relationships. CONCLUSION: AS has a substantial impact on patients' sexual relationships. Management of AS and its impact on sexual relationships should be directed not only towards physical outcomes such as disease activity and physical function, but also take into consideration the psychological state of the patient.

Development of the knee quality of life (KQoL-26) 26-item questionnaire: data quality, reliability, validity and responsiveness.

BACKGROUND: This article describes the development and validation of a self-reported questionnaire, the KQoL-26, that is based on the views of patients with a suspected ligamentous or meniscal injury of the knee that assesses the impact of their knee problem on the quality of their lives. METHODS: Patient interviews and focus groups were used to derive questionnaire content. The instrument was assessed for data quality, reliability, validity, and responsiveness using data from a randomised trial and patient survey about general practitioners' use of Magnetic Resonance Imaging for patients with a suspected ligamentous or meniscal injury. RESULTS: Interview and focus group data produced a 40-item questionnaire designed for self-completion. 559 trial patients and 323 survey patients responded to the questionnaire. Following principal components analysis and Rasch analysis, 26 items were found to contribute to three scales of knee-related quality of life: physical functioning, activity limitations, and emotional functioning. Item-total correlations ranged from 0.60-0.82. Cronbach's alpha and test retest reliability estimates were 0.91-0.94 and 0.80-0.93 respectively. Hypothesised correlations with the Lysholm Knee Scale, EQ-5D, SF-36 and knee symptom questions were evidence for construct validity. The instrument produced highly significant change scores for 65 trial patients indicating that their knee was a little or somewhat better at six months. The new instrument had higher effect sizes (range 0.86-1.13) and responsiveness statistics (range 1.50-2.13) than the EQ-5D and SF-36. CONCLUSION: The KQoL-26 has good evidence for internal reliability, test-retest reliability, validity and responsiveness, and is recommended for use in randomised trials and other evaluative studies of patients with a suspected ligamentous or meniscal injury.

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).

Patient satisfaction questionnaires for primary care out-of-hours services: a systematic review.

BACKGROUND: Patient satisfaction questionnaires are increasingly used for assessing quality of care. AIM: To review the evidence for the reliability and validity of patient satisfaction questionnaires for out-of-hours care. DESIGN: Systematic review. SETTING: Primary care out-of-hours services. METHOD: Searches of CINAHL, EMBASE, MEDLINE((R)) and PsycINFO using terms relevant to the measurement of patient satisfaction and out-of-hours services. Abstracts were reviewed and information relating to questionnaire content, data quality, reliability, and validity were extracted from articles by two independent researchers. RESULTS: Four questionnaires were found, two from the UK - the Patient Satisfaction with Out-of-Hours Care (PSOC) and Short Questionnaire for Out-of-Hours Care (SQOC) - and two from the Netherlands - the van Uden and Moll van Charante questionnaires. Questionnaire content was based on literature reviews and expert opinion; the PSOC and Moll van Charante questionnaires were also developed following interviews or focus groups with patients. Cronbach's alpha values were below 0.7 for some scales within the PSOC and van Uden questionnaires. Test-retest reliability was reported for the PSOC and Moll van Charante questionnaires. Tests of validity were few and did not give explicit consideration to the size of expected associations. CONCLUSION: Potential users wishing to assess patient satisfaction should carefully consider the content of the questionnaires and its relevance to the application and patient group. The four questionnaires have limitations relating to their development and evaluation. The PSOC and van Uden questionnaires have low levels of reliability for some scales, which should be used with caution in future surveys.

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.