External validation and diagnostic value of the Elderly Functional Index version 2.0 for assessing functional status and frailty in older Danish patients with gastrointestinal cancer receiving chemotherapy: A prospective, clinical study.

INTRODUCTION: Patient perspectives on functioning are often overlooked in oncology practice. This study externally validates the ELderly Functional Index (ELFI), a patient-reported measure for assessing multidimensional functioning, in older patients with gastrointestinal cancer receiving chemotherapy. The study compares ELFI scoring methods, evaluates its diagnostic value with geriatric oncology tools, and proposes a cut-off point for clinical use. MATERIALS AND METHODS: Danish patients aged ≥70 years with gastrointestinal cancer undergoing chemotherapy from a prospective, observational study were included. Two ELFI scoring methods, item-based and domain-based, were compared. Internal consistency reliability, validity, and correlations between ELFI, its component scales, and measures of functioning/frailty (including Eastern Cooperative Oncology Group Performance Status [ECOG-PS], Geriatric-8 [G8], Vulnerable Elders Survey-13 [VES-13], Timed-Up-and-Go [TUG], and 30-s chair stand test [30CST]) were investigated. Sensitivity and specificity analyses evaluated the ability of ELFI to predict frailty outcomes and identified frailty thresholds. Receiver operating characteristic analyses assessed the diagnostic ability of ELFI, alongside other measures, for oncological outcomes and frailty differentiation. Equipercentile equating methods enabled ECOG-PS, ELFI, and G8 mapping. RESULTS: One hundred fifty-four patients (median age 73.5 years, range 70-85) undergoing curative- or palliative-intent chemotherapy (49%) were included. ELFI demonstrated good internal consistency (Cronbach's alpha = 0.82) and acceptable convergent, structural, and discriminant validity. ELFI showed moderate to very strong correlations with its component scales (r = 0.40-0.93), and weaker correlations with frailty measures (r = 0.02-0.60). ELFI score < 80 indicated frailty risk, with almost fivefold risk of ECOG-PS 2 at follow-up (odds ratio[OR] = 4.8, 95% confidence interval [CI] 1.4-15.9), and predicted G8, VES-13, TUG, and 30CST frailty at follow-up, not completing planned chemotherapy (OR = 3.1; 95%CI 1.5-6.2), mono-therapy (OR = 3.5; 95%CI 1.5-8.1), initial dose reduction (OR = 4.9; 95%CI 2.0-12.1), and shorter overall survival (hazard ratio = 2.0, 95%CI 1.4-3.0). A preliminary crosswalk between ECOG-PS, ELFI, and G8 was established. DISCUSSION: ELFI was validated as a concise patient-reported measure of functional status in older patients with cancer and its relationship to frailty. ELFI demonstrated comparable predictive ability to other tools for oncological outcomes. Both scoring methods yielded similar results, with the domain-based method (ELFI v2.0) endorsed for consistency. ELFI v2.0 score of 80 was suggested as the frailty threshold in this population, supporting its clinical utility.

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force.

AIMS: Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. METHODS: We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. RESULTS: The database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. DISCUSSION: Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. SYSTEMATIC REVIEW REGISTRATION: PROSPERO No. CRD42018103179.

The Danish wound-quality of life (Wound-QoL) questionnaire: Translation and psychometric properties.

Hard to heal (HTH) wounds often result in a prolonged and painful healing process that affects different dimensions of patients' quality of life. Currently, there is no Danish patient-reported instrument to help professionals and patients identify and measure these different aspects of quality of life. Wound-quality of life (Wound-QoL) is a German 17-item questionnaire measuring dimensions of wound-specific quality of life. The aim was to translate and cross-culturally adapt the Wound-QoL into Danish and to evaluate its psychometric properties. Translation was conducted in accordance with international guidelines. Validity, reliability and responsiveness were evaluated in accordance with the COSMIN guideline. The Wound-QoL was successfully translated to Danish and content validity showed to be very good in a Danish context. A total of 172 patients with HTH wounds were included in the study and all participants completed the Wound-QoL. Out of these, respectively 54 and 155 patients were included in the analyses of test-retest reliability and responsiveness. Correlations for construct validity (EQ-5D-5L vs. Wound-QoL) ranged between 0.64 and 0.73. Cronbach's alpha values for internal consistency ranged between 0.77 and 0.92. Intra-class-correlation coefficients for test-rest reliability ranged between 0.73 and 0.88. Smallest detectable change scores at individual and group level ranged from 0.77 to 1.26 and 0.10 to 0.17, respectively. Minimal important change scores ranged from 1.20 to 1.33. Results of the responsiveness analyses showed sensitivity and specificity values between 56.1 to 62.2 and 57.7 to 63.2, respectively. In conclusion, the Danish Wound-QoL is a valid and reliable patient-reported outcome measure for assessing aspects of health-related quality of life in patients with hard ho heal wounds. However, the Wound-QoL demonstrated limited ability to discriminate between patients with clinically relevant improvements and patients that showed no changes. Thus, the responsiveness of the Wound-QoL should be taken into consideration if to be used as treatment effect measure.