Norwegian Version of the Chelsea Critical Care Physical Assessment Tool (CPAx-NOR): Translation, Face Validity, Cross-Cultural Adaptation and Inter-Rater Reliability.

BACKGROUND: Assessment of physical and respiratory function in the intensive care unit (ICU) is useful for developing an individualized treatment plan and evaluating patient progress. There is a need for measurement tools that are culturally adapted, reliable and easy to use. The Chelsea Critical Care Physical Assessment Tool (CPAx) is a valid measurement tool with strong psychometric properties for the intensive care population. This study aims to translate, adapt and test face validity and inter-rater reliability of the Norwegian version of CPAx (CPAx-NOR) for use in critically ill adult patients receiving prolonged mechanical ventilation. METHOD: CPAx-NOR was forward backward translated, culturally adapted and tested by experts and patients for face validity. Thereafter tested by 10 physiotherapists in five hospitals for inter-rater reliability. RESULTS: The experts and pilot testers reached consensus on the translation and face validity. Patients were tested at time point A (n = 57) and at time point B (n = 53). The reliability of CPAx-NOR at "A" was 0.990 (0.983-0.994) and at "B" 0.994 (0.990-0.997). Based on A+B combined and adjusted, the ICC was 0.990 (95% CI 0.996-0.998). Standard error of measurement (SEM) was 0.68 and the minimal detectable change (MDC) was 1.89. The Bland-Altman plot showed low bias and no sign of heteroscedasticity. CPAx-NOR changed with a mean score of 14.9, and showed a moderate floor effect at the start of physiotherapy and low ceiling effects at discharge. CONCLUSION: CPAx-NOR demonstrated good face validity and excellent inter-rater reliability. It can be used as an assessment tool for physical function in critically ill adults receiving prolonged mechanical ventilation in Norway.

Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review.

PURPOSE: Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. METHODS: A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific criteria and other key characteristics was assessed in a random sample of 150 eligible full-text publications from each year. Randomized controlled trials (RCTs) were assessed according to the full CONSORT-PRO checklist. RESULTS: The search identified 1692 publications in 2008 and 4290 in 2018. After screening of abstracts, 1240 from 2008 and 2869 from 2018 were clinical studies using PROs. By full-text review, the proportion of studies discussing PRO-specific limitations and implications was higher in 2018 than in 2008, but there were no differences in the other selected PRO-specific criteria. In 2018, a higher proportion of studies were longitudinal/cohort studies, included ≥ 300 patients, and used electronic administration of PRO than in 2008. The most common patient groups studied were those with cancer or diseases of the musculoskeletal system or connective tissue. CONCLUSION: The number of clinical studies from Europe using PROs was higher in 2018 than in 2008, but there was little difference in compliance with the PRO-specific criteria. The studies varied in terms of study design and PRO instruments used in both publication years.

Psychometric properties of the PROMIS-57 questionnaire, Norwegian version.

PURPOSE: The aims of this cross-sectional study were to explore reliability and validity of the Norwegian version of the Patient-Reported Outcome Measurement System®-Profile 57 (PROMIS-57) questionnaire in a general population sample, n = 408, and to examine Item Response properties and factor structure. METHODS: Reliability measures were obtained from factor analysis and item response theory (IRT) methods. Correlations between PROMIS-57 and RAND-36-item health survey (RAND36) were examined for concurrent and discriminant validity. Factor structure and IRT assumptions were examined with factor analysis methods. IRT Item and model fit and graphic plots were inspected, and differential item functioning (DIF) for language, age, gender, and education level were examined. RESULTS: PROMIS-57 demonstrated excellent reliability and satisfactory concurrent and discriminant validity. Factor structure of seven domains was supported. IRT assumptions were met for unidimensionality, local independence, monotonicity, and invariance with no DIF of consequence for language or age groups. Estimated common variance (ECV) per domain and confirmatory factor analysis (CFA) model fit supported unidimensionality for all seven domains. The GRM IRT Model demonstrates acceptable model fit. CONCLUSIONS: The psychometric properties and factor structure of Norwegian PROMIS-57 were satisfactory. Hence, the 57-item questionnaire along with PROMIS-29, and the corresponding 8 and 4 item short forms for physical function, anxiety, depression, fatigue, sleep disturbance, social participation ability and pain interference, are considered suitable for use in research and clinical care in Norwegian populations. Further studies on longitudinal reliability and sensitivity in patient populations and for Norwegian item calibration and/or reference scores are needed.

Health-related quality of life issues, including symptoms, in patients with active COVID-19 or post COVID-19; a systematic literature review.

PURPOSE: This systematic review was performed to identify all relevant health-related quality of life (HRQoL) issues associated with COVID-19. METHODS: A systematic literature search was undertaken in April 2020. In four teams of three reviewers each, all abstracts were independently reviewed for inclusion by two reviewers. Using a pre-defined checklist of 93 criteria for each publication, data extraction was performed independently by two reviewers and subsequently compared and discussed. If necessary, a third reviewer resolved any discrepancies. The search was updated in February 2021 to retrieve new publications on HRQoL issues including issues related to the long-term consequences of COVID-19. RESULTS: The search in April 2020 identified 3342 potentially relevant publications, and 339 publications were selected for full-text review and data extraction. We identified 75 distinct symptoms and other HRQoL issues categorized into 12 thematic areas; from general symptoms such as fever, myalgia, and fatigue, to neurological and psychological issues. The updated search revealed three extra issues experienced during active disease and long-term problems with fatigue, psychological issues and impaired cognitive function. CONCLUSION: This first comprehensive systematic review provides a detailed overview of the wide range of HRQoL issues experienced by patients with COVID-19 throughout the course of the disease. It demonstrates the devastating impact of the disease and provides critically important information for clinicians, to enable them to better recognize the disease and to provide knowledge important for treatment and follow-up. The results provided the foundation for the international development of a COVID-19 specific patient-reported HRQoL questionnaire.

Cross-cultural Adaptation and Validation of the Norwegian Short-form McGill Pain Questionnaire-2 in Low Back-related Leg Pain.

STUDY DESIGN: A prospective observational study with translation and psychometric analyses of a questionnaire. OBJECTIVE: Cross-cultural adaptation of the Short-Form McGill Pain Questionnaire-2 into Norwegian. SUMMARY OF BACKGROUND DATA: The different versions of the McGill Pain Questionnaire (MPQ) have been important and influential tools for pain assessment. To more reliably assess qualities of both neuropathic and non-neuropathic pain, the Short-Form MPQ was revised in 2009 (SF-MPQ-2), including seven additional descriptors. No Norwegian adaptation of the SF-MPQ-2 has been performed. METHODS: A translation of the SF-MPQ-2 was performed based on established guidelines. Forward-translations were compared and discussed in an expert workgroup. A synthesis was achieved by consensus. A backward translation was reviewed and consolidated with the forward translations to confirm linguistic equivalence. A prefinal version was tested in eight patients, who were interviewed to evaluate acceptability and comprehension of the questionnaire. Minor changes were implemented. The questionnaire was externally proofread. The final Norwegian version (NSF-MPQ-2) was tested for content and construct validity and internal consistency reliability in a population with low back-related leg pain. RESULTS: The backward translation was in good accordance with the original version. The prefinal version showed excellent acceptability and comprehension in initial patient-testing. The NSF-MPQ-2 showed satisfactory content and construct validity, including responsiveness to change, and acceptable internal consistency reliability as measured by Cronbach's alpha. A confirmatory factor analysis showed poor fit for the established four-factor structure, especially regarding the neuropathic subscale. CONCLUSION: The NSF-MPQ-2 showed excellent acceptability and comprehension, satisfactory content and construct validity, including responsiveness to change, and internal consistency reliability as measured by Cronbach's alpha. However, a confirmatory factor analysis raised concerns regarding the factor-structure in the present population. Until more evidence emerges for the four-factor solution we suggest the NSF-MPQ-2 should be used as a single measure. LEVEL OF EVIDENCE: 3.