BackgroundLupus nephritis (LN), a severe organ manifestation of systemic lupus erythematosus (SLE), significantly impacts health-related quality of life (HRQoL). Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Lupus Quality of Life (LupusQoL) have been validated to measure HRQoL in SLE, but not specifically in LN. Patient-reported symptoms of LN are not well-reported. We assessed the content validity and relevance of these measures in evaluating patients with LN and their LN-related experiences.MethodsThis qualitative, interview-based study enrolled patients with LN from three US sites from a larger, retrospective survey study. The interview comprised an open-ended concept elicitation part and a more structured cognitive part. Concept elicitation was used to identify relevant themes describing the patients’ experiences. Patients were asked to describe their LN-related symptoms, the severity and impact of those symptoms and their satisfaction with treatment. A cognitive interview approach evaluated the appropriate understanding of the items, instructions, and response options and asked patients about their understanding of the FACIT-Fatigue or LupusQoL measures, their relevance to the condition, and any aspects of confusion or need for better clarity of the questionnaires. All interviews were recorded and transcribed. The concept elicitation data were coded, while the cognitive interview data were tabulated to present the participants’ responses next to the interview questions to support the evaluation of their understanding of the questionnaire items.ResultsOverall, 10 patients participated in FACIT-Fatigue and another 10 in LupusQoL interviews; 18 patients were female, 10 were Black (self-reported) and 17 were receiving maintenance treatment for LN with stable disease activity. When patients recalled their symptoms, 670 expressions of varying symptoms were reported. All patients described pain, discomfort, and energy-related symptoms. Urinary frequency and non-joint swelling were most frequently attributed to LN rather than SLE. Patients felt the questions asked in the FACIT-Fatigue and LupusQoL surveys were relevant to their LN experience.ConclusionsThe symptoms reported by patients with LN were consistent with symptoms reported by the overall SLE population. However, patients indicated that some symptoms of LN were more profound than symptoms of SLE alone, affecting a broad range of areas of daily life activity and resulting in a higher burden on their HRQoL. FACIT-Fatigue and LupusQoL demonstrated content relevance as meaningful tools for patients with LN. However, further quantitative data collection is needed to ensure that these patient-reported outcome tools demonstrate good measurement properties in an LN population.

BackgroundPrevious research has suggested that alternative (respiratory) care providers (ACP) may provide affordable, accessible care for sleep-disordered breathing (SDB) that decreases wait-times and improves clinical outcomes. The objective of this study was to compare ACP-led and sleep physician-led care for SDB on patient reported outcome and experiences, with a focus on general and health-related quality of life, sleepiness, and patient satisfaction.MethodsWe conducted a secondary analysis of a randomized trial in which participants with severe SDB were assigned to either ACP-led or physician-led management. We created longitudinal linear mixed models to assess the impacts of treatment arm and timepoint on total and domain-level scores of multiple patient-reported outcome measures and patient-reported experience measures.ResultsPatients in both treatment arms (ACP-led n = 81; sleep-physician = 75) reported improved outcomes on the Sleep Apnea Quality of Life Index, Health Utilities Index, and Epworth Sleepiness Scale. Patients in each group had similar and clinically meaningful improvements on domains assessing cognition, emotion, and social functioning. The linear mixed models suggested no significant difference between treatment arms on the patient-reported outcomes. However, scores significantly improved over time.ConclusionsManagement of SDB using ACPs was comparable to physician-led care, as measured bypatient-reported outcome and experience measures. While loss to follow-up limits our findings, these results provide some support for the use of this novel health service delivery model to improve access to high quality SDB care.Clinical trial registrationThis is analysis of data from the study registered Clinicaltrials.gov (NCT02191085).

BackgroundAlthough quality of life (QOL) is an outcome of postoperative cardiac rehabilitation (CR), its course and related factors from postoperative hospitalization to the post-discharge period have not been adequately investigated. Additionally, the EuroQol-5Dimension-5Level (EQ-5D-5L) index score has not been characterized over the same period. We aimed to characterize QOL changes assessed by the EQ-5D-5L, over the period from hospitalization to 1 year post-discharge, in patients post-cardiac and thoracic aortic surgery, and investigate the factors associated with these temporal changes.MethodologyThis prospective, single-center study included 117 patients who underwent open cardiovascular surgery (median age, 72 years; men, 69%). Patients were assessed for QOL status when transferred to the general ward; at discharge; and at 6 and 12 months after discharge, using the EQ-5D-5L index score and a generalized linear mixed model with random intercepts. Patients were classified into two groups based on score changes post-discharge. Logistic regression analysis evaluated factors associated with QOL decrease post-discharge.ResultsThe EQ-5D-5L index score significantly increased over time, except between 6 and 12 months post-discharge; “Common activities” was the most common dimension showing score improvement. In 25 patients (21%), the EQ-5D-5L index scores were lower after discharge compared to their scores at discharge. In the logistic regression analysis, Barthel Index pre-admission, preoperative hemoglobin level, and Mini-Mental State Examination-Japanese scores pre-discharge were significantly associated with QOL decline after adjusting for the European System for Cardiac Operative Risk Evaluation II score.ConclusionsMost patients post-cardiac or thoracic aortic surgery experienced improved QOL from postoperative hospital stay to 1 year post-discharge. However, in patients with pre-operative basic activities of daily living, hemoglobin and post-operative cognitive decline may require ongoing comprehensive CR because of reduced QOL. Given the potential selection bias introduced by the relatively small sample size in this study, future research involving larger populations is necessary.

BackgroundThe University of Jyvaskyla Active Aging Scale (UJACAS) assesses active aging through willingness, ability, opportunity, and frequency of involvement in activities. Recognizing the lack of a German version, the Finnish original was translated (UJACAS-G). This study aimed: (1) to evaluate the test-retest reliability of UJACAS-G; and (2) to explore correlations with health-related parameters (concurrent validity).MethodsThe study (test-retest design) targeted healthy older adults aged 65+. Reliability of UJACAS-G (total and subscores) was assessed using Bland-Altman analyses and Intraclass Correlation Coefficients (ICCs). Furthermore, correlations (Spearman’s rho) between UJACAS-G scores and physical function (walking speed, handgrip strength, balance, 6-minute walk distance), physical activity (International Physical Activity Questionnaire), life-space mobility (Life-Space Assessment), and health-related quality of life (Short Form-36 Health Survey) were calculated.ResultsBland-Altman analyses (N = 60; mean age 72.3, SD 5.9 years; 50% women) revealed mean differences close to zero and narrow limits of agreement for all scores (total score: mean difference −1.9; limits −31.7 to 27.9). The ability subscore showed clustering at its upper limit. ICC was 0.829 (95% CI 0.730 to 0.894) for the total score and ranged between 0.530 and 0.876 for subscores (all p-values < 0.001). The total score correlated with walking speed (rho = 0.345; p = 0.008), physical activity (rho = 0.279; p = 0.033) and mental health (rho = 0.329; p = 0.010).ConclusionsUJACAS-G is reliable for assessing active aging among German-speaking healthy older adults. A potential ‘ceiling effect’ regarding the ability subscore should be considered when applying UJACAS-G to well-functioning populations. Analyses of concurrent validity indicated only weak correlations with health-related parameters.

BackgroundThe PedsQL™ 4.0 Generic Core Scales (GSC) have been translated into over 60 languages, but use in the sub-Saharan African region is limited. This study aimed to cross-culturally adapt and validate the PedsQL™ 4.0 GCS child self-report and teen self-report versions into the Chichewa language for Malawi.MethodsThe English (USA) versions were adapted (translation, back translation and cognitive interviews to evaluate conceptual equivalence) into Chichewa. We recruited 289 children (8–17 years) in Blantyre, Malawi. Classical psychometrics at the item level (missing data, endorsement frequencies, item redundancy) and scale level (internal consistency, convergent, discriminant and known groups validity) was used to evaluate the new Chichewa versions.ResultsSix items were found to need cultural adaptation for Malawi. There were problems with missing data (< 5%) and adjacent endorsement frequency (< 10%) among younger children. Internal consistency reliability was acceptable (Cronbach α > 0.7). Convergent validity was generally strong (correlations > 0.4). Discriminant validity (p > 0.05) was evident with respect to gender and age, but not for school grade (p < 0.05). Effect sizes indicating known groups validity were in the expected direction but of variable magnitude.ConclusionWe have successfully adapted the PedsQL™ 4.0 GCS child self-report and teen self-report into Chichewa for use in Malawi. Many aspects of the psychometric evaluation were promising, though some elements were more mixed and we have not yet been able to evaluate test-retest reliability or responsiveness. We suggest that the PedsQL™4.0 GCS child and teen self-reports should be used with caution among children and adolescents in Malawi.

BackgroundCancer-associated malnutrition is associated with worse symptom severity, functional status, quality of life, and overall survival. Malnutrition in cancer patients is often under-recognized and undertreated, emphasizing the need for standardized pathways for nutritional management in this population. The objectives of this study were to (1) investigate the relationship between malnutrition risk and self-reported symptom severity scores in an adult oncology outpatient population and (2) to identify whether a secondary screening tool for malnutrition risk (abPG-SGA) should be recommended for patients with a specific ESAS-r cut-off score or group of ESAS-r cut-off scores.MethodsA single-institution retrospective cross-sectional study was conducted. Malnutrition risk was measured using the Abridged Patient-Generated Subjective Global Assessment (abPG-SGA). Cancer symptom severity was measured using the Revised Edmonton Symptom Assessment System (ESAS-r). In accordance with standard institutional practice, patients completed both tools at first consult at the cancer centre. Adult patients who completed the ESAS-r and abPG-SGA on the same day between February 2017 and January 2020 were included. Spearman’s correlation, Mann Whitney U tests, receiver operating characteristic curves, and binary logistic regression models were used for statistical analyses.Results2071 oncology outpatients met inclusion criteria (mean age 65.7), of which 33.6% were identified to be at risk for malnutrition. For all ESAS-r parameters (pain, tiredness, drowsiness, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing), patients at risk for malnutrition had significantly higher scores (P < 0.001). All ESAS-r parameters were positively correlated with abPG-SGA score (P < 0.01). The ESAS-r parameters that best predicted malnutrition risk status were total ESAS-r score, lack of appetite, tiredness, and wellbeing (area under the curve = 0.824, 0.812, 0.764, 0.761 respectively). Lack of appetite score ≥ 1 demonstrated a sensitivity of 77.4% and specificity of 77.0%. Combining lack of appetite score ≥ 1 with total ESAS score > 14 yielded a sensitivity of 87.9% and specificity of 62.8%.ConclusionMalnutrition risk as measured by the abPG-SGA and symptom severity scores as measured by the ESAS-r are positively and significantly correlated. Given the widespread use of the ESAS-r in cancer care, utilizing specific ESAS-r cut-offs to trigger malnutrition screening could be a viable way to identify cancer patients at risk for malnutrition.

PurposeAlthough comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024.MethodsThe development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement.ResultsFrom the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review’s title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts.ConclusionPRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application.NoteIn order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

BackgroundThe EvalUation of goal-diRected activities to prOmote well-beIng and heAlth (EUROIA) scale is a novel patient-reported measure that was administered to individuals with chronic heart failure (CHF). It assesses goal-directed activities that are self-reported as being personally meaningful and commonly utilized to optimize health-related quality of life (HRQL). Our aim was to evaluate psychometric properties of the EUROIA, and to determine if it accounted for novel variance in its association with clinical outcomes.MethodsThis study was a secondary analysis of the CHF-CePPORT trial, which enrolled 231 CHF patients: median age = 59.5 years, 23% women. Baseline assessments included: EUROIA, Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS), Patient Health Questionnaire–9 for depression (PHQ-9), and the Generalized Anxiety Disorder–7 (GAD-7). 12-month outcomes included health status (composite index of incident hospitalization or emergency department, ED, visit) and mental health (PHQ-9 and GAD-7).ResultsExploratory Principal Axis Factoring identified four EUROIA factors with satisfactory internal reliability: i.e., activities promoting eudaimonic well-being (McDondald’s ω = 0.79), social affiliation (⍺=0.69), self-affirmation (⍺=0.73), and fulfillment of social roles/responsibilities (Spearman-Brown coefficient = 0.66). Multivariable logistic regression indicated that not only was the EUROIA inversely associated with incidence of 12-month hospitalization/ED visits independent of the KCCQ-OS (Odds Ratio, OR = 0.95, 95% Confidence Interval, CI, 0.91, 0.98), but it was also associated with 12-month PHQ-9 (OR = 0.91, 95% CI, 0.86, 0.97), and GAD-7 (OR = 0.94, 95% CI, 0.90, 0.99) whereas the KCCQ-OS was not.ConclusionThe EUROIA provides a preliminary taxonomy of goal-directed activities that promote HRQL among CHF patients independently from a current gold standard state-based measure.Clinical trial registrationNCT01864369; https://classic.clinicaltrials.gov/ct2/show/NCT01864369.Supplementary InformationThe online version contains supplementary material available at 10.1186/s41687-024-00723-x.

BackgroundPatient Reported Outcomes Measures (PROMs) are being used increasingly to measure health problems in stroke clinical practice. However, the implementation of these PROMs in routine stroke care is still in its infancy. To understand the value of PROMs used in ischemic stroke care, we explored the patients’ experience with PROMs and with the consultation at routine post-discharge follow-up after stroke.MethodsIn this prospective mixed methods study, patients with ischemic stroke completed an evaluation questionnaire about the use of PROMs and about their consultation in two Dutch hospitals. Additionally, telephone interviews were held to gain in-depth information about their experience with PROMs.ResultsIn total, 63 patients completed the evaluation questionnaire of which 10 patients were also interviewed. Most patients (82.2–96.6%) found completing the PROMs to be feasible and relevant. Half the patients (49.2–51.6%) considered the PROMs useful for the consultation and most patients (87.3–96.8%) reported the consultation as a positive experience. Completing the PROMs provided 51.6% of the patients with insight into their stroke-related problems. Almost 75% of the patients found the PROMs useful in giving the healthcare provider greater insight, and 60% reported discussing the PROM results during the consultation. Interviewed patients reported the added value of PROMs, particularly when arranging further care, in gaining a broader insight into the problems, and in ensuring all important topics were discussed during the consultation.ConclusionsCompleting PROMs appears to be feasible for patients with stroke attending post-discharge consultation; the vast majority of patients experienced added value for themselves or the healthcare provider. We recommend that healthcare providers discuss the PROM results with their patients to improve the value of PROMs for the patient. This could also improve the willingness to complete PROMs in the future.

BackgroundChronic obstructive pulmonary disease (COPD) and muscle weakness can cause impaired physical function, significantly impacting patients’ health-related quality of life (HRQoL). Loss of muscle strength is usually assessed through clinical and performance outcome (PerfO) assessments, which consists of tasks performed in a standardized manner, providing evidence of a patient’s functional ability. However, evidence documenting the patient experience of COPD and muscle weakness is limited.MethodsThis two-stage qualitative study used semi-structured interviews in patients aged 45–80 years with COPD (post-bronchodilator forced expiratory volume in 1s [FEV1]/forced vital capacity ratio < 0.70, and FEV1% predicted of 30–80%) and muscle weakness. In Stage 1, 30-minute concept elicitation interviews were conducted with participants recruited across three US sites to explore impacts on physical functioning and activities of daily living. In Stage 2, interviews were performed with participants exiting a Phase IIa trial investigating the efficacy of a selective androgen receptor modulator (GSK2881078) on leg strength, whereby PerfOs were used to evaluate strength and physical functioning endpoints. These participants completed either 60-minute in-depth (n = 32) or 15-minute confirmatory (n = 35) interviews exploring trial experience, completion of outcome measures, disease experience and treatment satisfaction.ResultsIn Stage 1 (n = 20), most participants described their muscles as weak (83.3%). Difficulties with walking (100%) and lifting heavy objects (90%) were reported. In Stage 2, 60-minute interviews, all participants (n = 32) reported a positive trial experience. Most participants reported that the home exercise program was easy to fit into daily life (77.8%), the PROactive daily diary was easy to complete (100%) and wearable sensors were easy to use (65.6%). However, technical issues were reported (71%), and few participants (19.4%) found physical assessments easy to complete. Improvements in muscle strength and functional limitations were reported by most participants. The shorter 15-minute confirmatory interviews (n = 35) supported the in-depth interview results.ConclusionThe qualitative interviews generated in-depth evidence of key concepts relevant to patients with COPD and muscle weakness and support the assessments of patient strength and physical function as outcome measures in this population in future studies.Trial numberGSK Stage 1: 206869; Stage 2: 200182, NCT03359473; Registered December 2, 2017, https://clinicaltrials.gov/ct2/show/NCT03359473.