Outcome Measure For Fatigue Research Articles

N37 Inflammatory Bowel Disease-Fatigue (IBD-F) patient self-assessment scale and its use in research and clinical practice - a systematic review

Abstract Background Individuals living with inflammatory bowel disease (IBD) report fatigue as most common and disabling symptom, with 86% reporting fatigue in active IBD and 50% in remission. It is however, poorly understood and inadequately addressed in clinical setting. There are several scales that have been used to assess fatigue in IBD (1), however only the IBD-F patient self-assessment scale (2) has been developed and validity tested with people with IBD. The IBD-F scale has been recommended as the gold standard by recent literature review (3). The aim of the current review is to understand the IBD-F scale usage in clinical and academic environments and what impact the scale has had since its publication in clinical practice and research including utilisation. Methods We searched AMED (APA PsycInfo, CINAHL Plus, Medline), Embase, Scopus, PubMed, Psycarticles from Jan 2014 (date of the IBD-F scale publication) to Jul 30, 2023, to identify the studies reporting the use and/or translation of the IBD-F scale. Studies were eligible if they used the IBD-F scale and were written in English, unless a translation was made available. Titles and abstracts screening and data extraction were conducted by two reviewers independently. Results In total 1457 references were identified from the databases, imported to Covidence and duplicates (n=365) removed. Titles and abstracts (n=1092) screening resulted in 21studies fulfilling the eligibility criteria; five cross-sectional surveys, four randomised controlled trials (RCTs), and 12 translation and validation studies. All were high or medium quality. The total population size of the included studies was 6126 participants (30-1700 range) of which 3612 were females. Due to heterogeneity of studies, meta-analysis was precluded. Most studies (n=15) were conducted in one country (UK, Denmark, China, Korea, Germany, Iran and Mexico) and six were international collaborations (Greece/UK, Brazil/UK, Denmark/Norway, Netherlands/UK, Poland/UK, and Bulgaria/France/Israel/Norway/Italy/Spain/Sweden/UK). This indicates a broad international focus on IBD fatigue. Most studies (n=17) concentrated on factors contributing to and measuring prevalence and severity of fatigue. Only four were RCTs focusing of fatigue management. Conclusion The IBD-F scale is a tool with a high content and face validity to assess the multidimensional nature of fatigue experienced by individuals with IBD. The IBD-F scale has been primarily used in clinical and academic research. There were no studies reporting using IBD-F scale in clinical practice. Health professionals need to adopt the scale in clinical practice to systematically assess and manage IBD fatigue. References (1)Borren NZ, van der Woude JC and Ananthakrishnan AN. Fatigue in IBD: epidemiology, pathophysiology and management. Nature Reviews Gastroenterology & Hepatology. 2019 Apr;16(4):247-259. https://doi:10.1038/s41575-018-0091-9 (2)Czuber-Dochan W, Norton C, Bassett P, et al. Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale. JCC. 2014 Nov; 8(11):1398-1406. https://doi.org/10.1016/j.crohns.2014.04.013 (3)Fan VSK, Mehdipour A, O'Grady, et al. Systematic review: patient-reported outcome measures of fatigue in inflammatory bowel disease. Fatigue: Biomedicine, Health & Behavior. 2022 May; 10(2):60-82. https://doi.org/10.1080/21641846.2022.2073157

Comparison of patient-reported symptoms with multi-item patient-reported outcome measures of fatigue, anxiety, and depression in the clinical care of women undergoing chemotherapy for early breast cancer.

As patient-reported symptoms are increasingly incorporated into routine clinical practice and captured in electronic medical records these data can be used to conduct health-related quality of life research studies. This study compares symptom reports from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and its precursor patient reported symptom monitoring (PRSM) (hereafter PRSM/PRO-CTCAE) with multi-item patient-reported outcome (PRO) scales for fatigue (Functional Assessment of Chronic Illness Therapy/FACIT-Fatigue) and depression and anxiety (Mental Health Index/MHI). This is a secondary analysis of data collected from women with early breast cancer (Stage I-III) scheduled for chemotherapy who completed PRSM/PRO-CTCAE, FACIT-Fatigue, and MHI scales pre- and post-chemotherapy. Spearman correlation coefficients estimated the magnitude and direction of correlations between measures (convergent validity). For each symptom, patients were then categorized based on who improved, stayed the same, or worsened on the composite PRSM/PRO-CTCAE score, and changes in scores on the PRO scales were compared. In a sample of 374 women, mean age was 57years (SD 12.6) with 76% White. PRSM/PRO-CTCAE fatigue measures were strongly correlated with FACIT-Fatigue total scale and had mixed moderate to strong correlation for individual items within the FACIT-Fatigue scale. PRSM/PRO-CTCAE Sad and Anxiety measures were strongly correlated with MHI-Depression and MHI-Anxiety total scales, respectively, and had mixed moderate to strong correlation with individual items within the MHI subscales. PRSM/PRO-CTCAE pre-post changes in symptom scores mirrored pre-post changes in FACIT-Fatigue and MHI subscales.

Minimal and robust clinically important differences for patient-reported outcome measures of fatigue in chronic stroke survivors after fatigue rehabilitation

Purpose The minimal and robust clinically important difference (MCID and/or RCID) are essential in assessing the clinical significance of multidimensional fatigue inventory-20 and checklist of individual strength-fatigue subscale questionnaires changes scores. This is the first study to determine the MCID and RCID of these questionnaires in chronic stroke survivors. Materials and methods A total of 125 participants in an observational cohort study completed MFI-20 and CIS-fs before and after receiving multidisciplinary rehabilitation (cognitive behavioral therapy, graded exercise and adaptive pacing therapy). Anchor-based MCIDs and RCIDs were calculated using the mean change, the mean difference and the receiver operating characteristics methods. To evaluate the accordance between of distribution-based MCIDs (1 SD, ½ SD, SEM, 1.96 SEM and MDC values) with anchored values, the accuracy, sensitivity, specificity and Youden’s index were calculated. Results The anchored MCIDs were between −5 to −7.33 for MFI-20 and −4.87 to −5.40 for CIS-fs. The anchored RCIDs ranged from −5 to −13.88 and −6 to −9.88 for MFI-20 and CIS-fs, respectively. The values of ½ SD and SEM for CIS-fs were consistent with anchored RCIDs. Conclusions The estimated MCIDs and RCIDs of MFI-20 and CIS-fs can help researchers and clinicians interpret their chronic stroke patient data.

Efficacy of Exercise Therapy on Fatigue Levels of Patients with Multiple Sclerosis: A Literature Review

Introduction: Multiple sclerosis is a disease of the central nervous system caused by the immune system and it affects people all over the world. It is characterised by a variety of symptoms. Excessive fatigue is the most prevalent and debilitating symptom in individuals with multiple sclerosis, significantly impacting their lives. Several factors contribute to the disease and physical inactivity, which have been suggested to impact fatigue levels. Regular exercise therapy has the potential to alter psychological and physiological functions that can significantly improve fatigue in multiple sclerosis patients. Aim: To review the existing literature on the efficacy of exercise therapy on fatigue levels of multiple sclerosis patients. Materials and Methods: The authors conducted a literature search from 2014-2024 using different search engines such as Google Scholar, PubMed, Physiotherapy Evidence Database (PEDro), Cochrane Library and Scopus. The search utilised MeSH (Medical Subject Headings) keywords including exercise, multiple sclerosis, and fatigue. The authors included all types of studies that examined the efficacy of exercise interventions on fatigue outcome measures. Results: Exercise therapy was a safe intervention for multiple sclerosis patients and did not cause any harm. A combination of exercise programs were used to improve fatigue levels and the quality of life of multiple sclerosis patients. Both subjective and objective outcome measures showed significant changes in fatigue levels. Conclusion: Exercise therapy has shown promising results in improving the overall health of multiple sclerosis patients, particularly in reducing fatigue levels. There is a need for more focus on designing non stereotypical treatment protocols and evaluating them using gold-standard tools. The International Classification of Functioning, Disability and Health (ICF) model can be incorporated to identify more effective treatment and assessment methods.

Self-management strategies in people with heart failure-related fatigue: a systematic review

Background: Fatigue is a common symptom of heart failure which can be distressing for patients and negatively impact both their quality of life and prognosis. We report the efficacy of self-management strategies for people with heart failure-related fatigue. Methods and results: We searched the MEDLINE, Psychinfo, Emcare and Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception to August 2021 for relevant trials. Twenty-two papers were included describing 21 trials (15 RCTs), comprising 515 participants. Definitions of interventions are given and were grouped as either supported self-management or self-management interventions. Supported self-management included education and person-centred care interventions (n=5). Self-management interventions included mind-body therapies (10), and diet and supplements (6). The Cochrane risk of bias did not show significant high risk across the domains, however the number of participants recruited was small (515 participants in total). There was heterogeneity in intervention type, delivery and outcome measures preventing meta-analysis. Evidence for supported self-management interventions involving education and a person-centred approach, and self-management interventions such as CBT, mindfulness, and some supplements for heart failure-related fatigue is positive, but is limited to individual, small trials. Only eight trials provided a definition of fatigue, and 11 types of fatigue outcome measures were used. Conclusion: The evidence base for the efficacy of supported self-management and self-management interventions for alleviating heart failure-related fatigue is modest in both study number, size, and quality. Further well-designed trials are needed, along with consensus work on fatigue definitions and reporting.

The development of a patient reported outcome measure for fatigue and breathlessness for patients with chronic heart failure (OxFAB)

BackgroundFatigue and breathlessness are the two most common and distressing symptoms for patients with chronic heart failure. They affect a patient's quality of life and ability to undertake activities of daily living. Currently there are no symptom specific measures for fatigue and breathlessness available or developed and validated for use with this patient group and no questionnaire that incorporates both symptoms into one measure. ObjectiveTo develop a patient-reported outcome measure for patients with chronic heart failure for their fatigue and breathlessness symptoms. MethodsA three-staged, approach was used. In stage One in-depth qualitative patient-interviews on factors of fatigue and breathlessness in chronic heart failure were undertaken to provide question themes. Items from these interviews were generated and pilot questionnaires developed and tested. In Stage Two, exploratory factor analysis with item reduction and final testing of the questionnaire was performed. Stage Three involved validation testing. ResultsIn Stage One, issues raised in interviews (n = 25) were used to generate items. Pilot questionnaires were developed and tested. Items were refined in the context of cognitive debrief interviews (n = 7) for possible inclusion in the final measure. Final testing of questionnaire properties with item reduction was carried out in Stage Two (n = 112). Validity and reliability were assessed in Stage Three (n = 96). Psychometric testing showed positive results, in internal consistency (Cronbach's alpha ranging from 0.8 to 0.94) and test-retest (no difference in means), content validity and relevance to patients. ConclusionsThis questionnaire could be useful in the assessment of fatigue and breathlessness in patients living with chronic heart failure.

Interventions for the management of fatigue in adults with a primary brain tumour.

Fatigue is a common and disabling symptom in people with a primary brain tumour (PBT). The effectiveness of interventions for treating clinically significant levels of fatigue in this population is unclear. This is an updated version of the original Cochrane Review published in Issue 4, 2016. To assess the effectiveness and safety of pharmacological and non-pharmacological interventions for adults with PBT and clinically significant (or high levels) of fatigue. For this updated review, we searched CENTRAL, MEDLINE and Embase, and checked the reference lists of included studies in April 2022. We also searched relevant conference proceedings, and ClinicalTrials.gov for ongoing trials. We included randomised controlled trials (RCTs) that investigated any pharmacological or non-pharmacological intervention in adults with PBT and fatigue, where fatigue was the primary outcome measure. We restricted inclusion specifically to studies that enrolled only participants with clinically significant levels of fatigue to improve the clinical utility of the findings. Two review authors (JD, DC) independently evaluated search results for the updated search. Two review authors (JD, SYK) extracted data from selected studies, and carried out a risk of bias assessment. We extracted data on fatigue, mood, cognition, quality of life and adverse events outcomes. The original review identified one study and this update identified a further two for inclusion. One study investigated the use of modafinil, one study the use of armodafinil and one study the use of dexamfetamine. We identified three ongoing studies. In the original review, the single eligible trial compared modafinil to placebo for 37 participants with a high- or low-grade PBT. One new study compared two doses of armodafinil (150 mg and 250 mg) to placebo for 297 people with a high-grade glioma. The second new study compared dexamfetamine sulfate to placebo for 46 participants with a low- or high-grade PBT. The evidence was uncertain for both modafinil and dexamfetamine regarding fatigue outcome measures, compared to controls, at study endpoint. Two trials did not reach the planned recruitment target and therefore may not, in practice, have been adequately powered to detect a difference. These trials were at a low risk of bias across most areas. There was an unclear risk of bias related to the use of mean imputation for one study because the investigators did not analyse the impact of imputation on the results and information regarding baseline characteristics and randomisation were not clear. The certainty of the evidence measured using GRADE was very low across all three studies. There was one identified study awaiting classification once data are available, which investigated the feasibility of 'health coaching' for people with a PBT experiencing fatigue. There were three ongoing studies that may be eligible for an update of this review, all investigating a non-pharmacological intervention for fatigue in people with PBT. There is currently insufficient evidence to draw reliable and generalisable conclusions regarding potential effectiveness or harm of any pharmacological or non-pharmacological treatments for fatigue in people with PBT. More research is needed on how best to treat people with brain tumours with high fatigue.

Beyond the hand and upper extremity: The role of hand therapists in care of people with rheumatic diseases

Study designInvited Clinical Commentary BackgroundArthritis is one of the most frequently reported causes of disability in the United States and the prevalence is expected to increase in the coming decades. While many rheumatic diseases involve hand impairments, most are systemic and involve more than the musculoskeletal system. Functional and work disability are high and people would benefit from the services of occupational and physical therapists. Purpose of studyThis paper reviews concepts of self-management, and symptoms that contribute to limitations and restrictions to participation in daily life in people with rheumatic diseases and suggests roles for hand therapists beyond the immediate hand impairments. MethodsThe impact of selected rheumatic diseases on functional and work disability are reviewed along with strategies for symptom management and self-management. Upper extremity impairments of selected rheumatic diseases are also discussed. ResultsThe role for hand therapists in evaluating and addressing the complex needs of persons with rheumatic diseases, including less common diseases, is discussed. Outcome measures for fatigue, muscle involvement, ergonomics and computer use, and work disability are introduced. Finally, strategies for self-management and prevention of work and functional disability, along with symptom management for fatigue and pain are presented. ConclusionHand therapists can play a vital role in chronic rheumatic disease management to improve self-management and increase participation in meaningful activities. Patients, primary care and rheumatology providers need to be educated about the scope of services occupational and physical therapists provide beyond the hand impairments.

Cancer-Related Fatigue Outcome Measures in Integrative Oncology: Evidence for Practice and Research Recommendations.

Cancer-related fatigue (CRF) is one of the most common symptoms across the cancer continuum and is often underreported and undertreated. Defined as a distressing, persistent, subjective sense of tiredness or exhaustion related to cancer or its treatment, CRF includes physical, emotional, cognitive, and spiritual dimensions. Patient-reported outcome (PRO) measures are the most widely used tool to screen for and assess fatigue and the associated negative impacts on quality of life. However, selecting subjective CRF measures can be complex. This has resulted in the availability of and inconsistent use of numerous PROs, limiting the ability to cross-compare outcomes clinically and within research. To address this, the PROs that are most widely reported in the literature are recommended to support the standardization of a core set of validated measures. The National Comprehensive Cancer Network single-item tool for clinical significance is recommended for quick use in clinical environments; the Brief Fatigue Inventory allows for fast, easy, helpful cutoffs on severity threshold for triage, and measures both severity and interference with daily functioning; while the MD Anderson Symptom Inventory allows for multisymptomatic assessment. In addition, a fundamental consideration for any PRO use is the administrative burden on the patient and clinician. In this review, we aim to summarize current, validated PROs specific to CRF to aid clinicians and researchers in patient care and in study design and implementation. We conclude with suggestions for future directions in CRF research that can increase the possibility for long-term impact on future guidelines of fatigue management.

A mixed-methods systematic review of post-viral fatigue interventions: Are there lessons for long Covid?

Fatigue syndromes have been widely observed following post-viral infection and are being recognised because of Covid19. Interventions used to treat and manage fatigue have been widely researched and this study aims to synthesise the literature associated with fatigue interventions to investigate the outcomes that may be applicable to 'long Covid'. The study was registered with PROSPERO (CRD42020214209) in October 2020 and five electronic databases were searched. Papers were screened, critically appraised and data extracted from studies that reported outcomes of fatigue interventions for post-viral syndromes. The narrative synthesis includes statistical analysis associated with effectiveness and then identifies the characteristics of the interventions, including identification of transferable learning for the treatment of fatigue in long Covid. An expert panel supported critical appraisal and data synthesis. Over 7,000 research papers revealed a diverse range of interventions and fatigue outcome measures. Forty papers were selected for data extraction after final screening. The effectiveness of all interventions was assessed according to mean differences (MD) in measured fatigue severity between each experimental group and a control following the intervention, as well as standardised mean differences as an overall measure of effect size. Analyses identified a range of effects-from most effective MD -39.0 [95% CI -51.8 to -26.2] to least effective MD 42.28 [95% CI 33.23 to 51.34]-across a range of interventions implemented with people suffering varying levels of fatigue severity. Interventions were multimodal with a range of supportive therapeutic methods and varied in intensity and requirements of the participants. Those in western medical systems tended to be based on self- management and education principles (i.e., group cognitive behavioural therapy (CBT). Findings suggest that the research is highly focussed on a narrow participant demographic and relatively few methods are effective in managing fatigue symptoms. Selected literature reported complex interventions using self-rating fatigue scales that report effect. Synthesis suggests that long Covid fatigue management may be beneficial when a) physical and psychological support, is delivered in groups where people can plan their functional response to fatigue; and b) where strengthening rather than endurance is used to prevent deconditioning; and c) where fatigue is regarded in the context of an individual's lifestyle and home-based activities are used.

Validation of a Core Patient-Reported Outcome Measure for Fatigue in Patients Receiving Hemodialysis: The SONG-HD Fatigue Instrument.

Fatigue is a very common and debilitating symptom and identified by patients as a critically important core outcome to be included in all trials involving patients receiving hemodialysis. A valid, standardized measure for fatigue is needed to yield meaningful and relevant evidence about this outcome. This study validated a core patient-reported outcome measure for fatigue in hemodialysis. A longitudinal cohort study was conducted to assess the validity and reliability of a new fatigue measure (Standardized Outcomes in Nephrology-Hemodialysis Fatigue [SONG-HD Fatigue]). Eligible and consenting patients completed the measure at three time points: baseline, a week later, and 12 days following the second time point. Cronbach α and intraclass correlation coefficient were calculated to assess internal consistency, and Spearman rho was used to assess convergent validity. Confirmatory factor analysis was also conducted. Hemodialysis units in the United Kingdom, Australia, and Romania participated in this study. Adult patients aged 18 years and over who were English speaking and receiving maintenance hemodialysis were eligible to participate. Standardized Outcomes in Nephrology-Hemodialysis, the Visual Analog Scale for fatigue, the 12-Item Short Form Survey, and Functional Assessment of Chronic Illness Therapy-Fatigue were used. In total, 485 participants completed the study across the United Kingdom, Australia, and Romania. Psychometric assessment demonstrated that Standardized Outcomes in Nephrology-Hemodialysis is internally consistent (Cronbach α =0.81-0.86) and stable over a 1-week period (intraclass correlation coefficient =0.68-0.74). The measure demonstrated convergence with Functional Assessment of Chronic Illness Therapy-Fatigue and had moderate correlations with other measures that assessed related but not the same concept (the 12-Item Short Form Survey and the Visual Analog Scale). Confirmatory factor analysis supported the one-factor model. SONG-HD Fatigue seems to be a reliable and valid measure to be used in trials involving patients receiving hemodialysis.

Minimal Clinically Important Differences for Patient-Reported Outcome Measures of Fatigue in Patients With COPD Following Pulmonary Rehabilitation

Fatigue is a burdensome and prevailing symptom in patients with COPD. Pulmonary rehabilitation (PR) improves fatigue; however, interpreting when such improvement is clinically relevant is challenging. Minimal clinically important differences (MCIDs) for instruments assessing fatigue are warranted to better tailor PR and guide clinical decisions. This study estimated MCIDs for the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-FS), the modified FACIT-FS, and the Checklist Individual Strength-Fatigue Subscale in patients with COPD following PR. Data from patients with COPD who completed a 12-week community-based PR program were used to compute the MCIDs. The pooled MCID was estimated by calculating the arithmetic weighted mean, resulting from the combination of anchor-based (weight, two-thirds) and distribution-based (weight, one-third) methods. Anchors were patients' and physiotherapists' Global Rating of Change Scale, COPD Assessment Test, St. George's Respiratory Questionnaire (SGRQ), and exacerbations. To estimate MCIDs, we used mean change, receiver-operating characteristic curves, and linear regression analysis for anchor-based approaches, and 0.5× SD, SE of measurement, 1.96× SE of measurement, and minimal detectable change for distribution-based approaches. Fifty-three patients with COPD (79%male, 68.4 ± 7.6 years of age, and FEV1 48.7 ± 17.4%predicted) were included in the analysis. Exacerbations and the SGRQ-impact and the SGRQ-total scores fulfilled the requirements to be used as anchors. Pooled MCIDs were 4.7 for FACIT-FS, 3.8 for the modified FACIT-FS, and 9.3 for the Checklist Individual Strength-Fatigue Subscale. The MCIDs proposed in this study can be used by different stakeholders to interpret PR effectiveness. ClinicalTrials.gov; No.: NCT03799666; URL: www.clinicaltrials.gov.

Identifying dimensions of fatigue in haemodialysis important to patients, caregivers and health professionals: An international survey.

Patient-reported outcome measures of fatigue used in research in haemodialysis vary widely in the dimensions assessed; and the importance of these dimensions to patients and health professionals is unknown. This study aimed to identify the most important dimensions of fatigue to assess in patients on haemodialysis participating in trials. In an international survey, patients/caregivers and health professionals rated the absolute and relative importance of content and measurement dimensions to include in a core outcome measure of fatigue. A 9-point Likert scale (7-9 indicating critical importance) was used to assess absolute importance and best-worst scale was used to assess importance of each dimension compared to others. In total, 169 patients/caregivers and 336 health professionals from 60 countries completed the survey. Both groups (patients/caregivers and health professionals) rated life participation (7.55), tiredness (7.40), level of energy (7.37), ability to think clearly (7.15), post-dialysis fatigue (7.13), motivation (7.03) and ability to concentrate (7.03) as critically important (mean Likert score greater than 7) content dimensions to include in a core outcome measure. Compared to patients and caregivers, health professionals rated post-dialysis fatigue, memory and verbal abilities more highly. Based on the relative importance scores, life participation was ranked most highly above all content dimensions. Severity was rated and ranked the most important measurement dimension by all stakeholders. A core outcome measure of fatigue should assess impact of fatigue on life participation, tiredness and level of energy, using a severity scale. A consistent and valid measurement of fatigue will improve the value of trials in supporting decision-making based on this important outcome.

Minimally important difference of the fatigue severity scale and modified fatigue impact scale in people with multiple sclerosis

BackgroundFatigue is a common and debilitating symptom of Multiple Sclerosis (MS); however, it is unknown what constitutes a clinically significant change in fatigue. Establishing the minimally important difference (MID) of fatigue outcome measures can inform the interpretation of changes in fatigue by estimating the level of change that is considered clinically relevant. AimDetermine the MID for the Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS) in people with MS. MethodsThis cross-sectional study collected information on self-reported fatigue (FSS and MFIS) and quality of life (EQ-5D and MS Impact Scale 29) through an online survey. Anchor-based methods were used to estimate MID, and ordinal logistic regression models were used to determine the difference in fatigue that would predict a significant effect on quality of life. Results365 people with MS (81.9% female, 69.3% relapsing-remitting MS, mean age 46.2 ± 11.6 years, mean time since diagnosis 9.6 ± 8.7 years) responded to the survey. MID estimates for the FSS and MFIS ranged from 0.45–0.88 and 3.86–8.11 respectively, accounting for 6.4–12.6% of maximum FSS score and 4.6–9.7% of maximum MFIS score. ConclusionsMID estimates derived from this study indicate that a difference of at least 0.45 points on the FSS or 4 points on the MFIS constitutes a clinically significant difference in fatigue. Therefore, these estimates represent a threshold value which can be used to interpret changes in the FSS and MFIS over time or in response to an intervention.

SUN-096 STANDARDIZED OUTCOMES IN NEPHROLOGY-HEMODIALYSIS (SONG-HD): DEVELOPING A CORE OUTCOME MEASURE FOR FATIGUE IN HEMODIALYSIS

As part of the Standardized Outcomes in Nephrology-Hemodialysis program of work, to establish a core outcomes set for all trials in hemodialysis, fatigue was identified as one of the five core outcomes. However, although fatigue is common and debilitating for patients on hemodialysis, it is infrequently and inconsistently reported in clinical trials in this setting. Through a four-phase process we aimed to establish a core outcome measure for fatigue to facilitate standardized and accurate assessment of this outcome in all hemodialysis trials. We conducted 1) a systematic review of studies to assess the range, validity and frequency of fatigue measures used, 2) an international survey with patients and health professionals to identify the most important dimensions to assess in a fatigue measure among the varying content of existing measures identified in the review, 3) a consensus workshop including patients and health professionals including nephrologists, researchers, and policy makers to discuss content validity, feasibility and implementation, and 4) a pilot of the proposed outcome measure using cognitive interviews assessing comprehension, retrieval, judgement and response In the systematic review, we identified 43 different measures across 123 included studies with widely varying content, response scale, length, and cost. In total, 658 participants (313 [48%] patients and caregivers and 345 [52%] health professionals) from 60 countries completed the survey. Life participation (impact of fatigue on the ability to participate in usual activities) was identified as the most important dimension of fatigue. Themes from the consensus workshop indicated that life participation, along with tiredness and level of energy, would form relevant and meaningful content for the proposed outcome measure. Participants emphasized that the measure had to be simple, short, without imposing additional burden given the high level of fatigue in this population. Integrating these findings, the resulting 3-item measure was designed to assess life participation, tiredness and level of energy. All three items are on a 4-point Likert scale indicating severity. As recommended, a recall period of a week was chosen for this measure. The full measure can be seen in Figure 1. In the pilot study, the proposed outcome measure was deemed relevant and acceptable in all four aspects of the cognitive interview framework Patients and health professionals support the need for a simple, short and meaningful core patient-reported outcome measure that assesses level of energy, tiredness and impact of fatigue on the ability to participate in life activities. These aspects were integrated in the development of the proposed outcome measure for fatigue, to enable a valid and patient-centered assessment of this critical outcome

Establishing a Core Outcome Measure for Fatigue in Patients on Hemodialysis: A Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Consensus Workshop Report

Fatigue is one of the most highly prioritized outcomes for patients and clinicians, but remains infrequently and inconsistently reported across trials in hemodialysis. We convened an international Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) consensus workshop with stakeholders to discuss the development and implementation of a core outcome measure for fatigue. 15 patients/caregivers and 42 health professionals (clinicians, researchers, policy makers, and industry representatives) from 9 countries participated in breakout discussions. Transcripts were analyzed thematically. 4 themes for a core outcome measure emerged. Drawing attention to a distinct and all-encompassing symptom was explicitly recognizing fatigue as a multifaceted symptom unique to hemodialysis. Emphasizing the pervasive impact of fatigue on life participation justified the focus on how fatigue severely impaired the patient's ability to do usual activities. Ensuring relevance and accuracy in measuring fatigue would facilitate shared decision making about treatment. Minimizing burden of administration meant avoiding the cognitive burden, additional time, and resources required to use the measure. A core outcome measure that is simple, is short, and includes a focus on the severity of the impact of fatigue on life participation may facilitate consistent and meaningful measurement of fatigue in all trials to inform decision making and care of patients receiving hemodialysis.

Patient-Reported Outcome Measures for Fatigue in Patients on Hemodialysis: A Systematic Review

Fatigue is a prevalent and debilitating symptom in patients receiving hemodialysis. We aimed to identify and evaluate the characteristics and psychometric properties of patient-reported outcome measures for fatigue in patients receiving hemodialysis, to inform the selection of a robust and feasible measure for use in randomized trials in hemodialysis. Systematic review of outcome measures for fatigue. Patients receiving hemodialysis. MEDLINE, Embase, PsycINFO, and CINAHL from inception to April 2017 were searched for all studies that reported fatigue in patients receiving hemodialysis. With a focus on addressing methods, items (individual questions) from all measures were categorized into content and measurement dimensions of fatigue. We assessed the general characteristics (eg, number of items and cost) and psychometric properties of all measures. From 123 studies, we identified 43 different measures: 24 (55%) were developed specifically for the hemodialysis population (of which 18 were nonvalidated author-developed measures for use in their study only), 17 (40%) for other populations, and 2 (5%) for chronic kidney disease (all stages). The measures assessed 11 content dimensions of fatigue, the 3 most frequent being level of energy (19 [44%]), tiredness (15 [35%]), and life participation (14 [33%]); and 4 measurement dimensions: severity (34 [79%]), frequency (10 [23%]), duration (4 [9%]), and change (1 [2%]). The vitality subscale of the 36-Item Short Form Health Survey (SF-36) was the most frequently used (19 [15%] studies), but has only been tested for reliability in hemodialysis. Of the fatigue-specific measures, the Chalder Fatigue Scale was the only one evaluated in hemodialysis, but the full psychometric robustness remains uncertain. For feasibility, we searched for validation studies in the hemodialysis population using the names of measures identified in the primary search strategy. A very wide range of measures have been used to assess fatigue in patientsreceiving hemodialysis, each varying in content and length. Many have limited validation data available in this population. A standardized and psychometrically robust measure that captures dimensions of fatigue that are important to patients is needed to estimate andimprove this disabling complication of hemodialysis.

The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome.

Debilitating fatigue is a core symptom of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); however, the utility of patient-reported symptom outcome measures of fatigue for ME/CFS patients is problematic due to ceiling effects and issues with reliability and validity. We sought to evaluate the performance of three patient-reported symptom measures in a sample of ME/CFS patients and matched controls. Two hundred and forty ME/CFS patients and 88 age, sex, race, and zip code matched controls participated in the study. Participants completed the Multidimensional Fatigue Inventory-20, DePaul Symptom Questionnaire, and RAND SF-36. The general and physical fatigue subscales on Multidimensional Fatigue Inventory-20, as well as the role of physical health on the RAND SF-36, demonstrated questionable or unacceptable internal consistency and problematic ceiling effects. The DePaul Symptom Questionnaire demonstrated excellent internal reliability, and less than 5% of participants were at the ceiling on each subscale. The post-exertional malaise subscale on the DePaul Symptom Questionnaire demonstrated excellent clinical utility as it was able to differentiate between ME/CFS patients and controls (OR 1.23, p<.001) and predicted ceiling effects on other patient-reported outcome subscales. A score of 20 on the post-exertional malaise subscale of the DePaul Symptom Questionnaire optimally differentiated between patients and controls. Significant ceiling effects and concerns with reliability and validity were observed among Multidimensional Fatigue Inventory-20 and RAND SF-36 subscales for ME/CFS patients. The DePaul Symptom Questionnaire addresses a number of concerns typically identified when using patient-reported outcome measures with ME/CFS patients; however, an improved multidimensional patient-reported outcome tool for measuring ME/CFS-related symptoms is warranted.

Effects of a walking program on fatigue and exercise capacity in post-surgery breast cancer women

The majority of women with breast cancer experience treatment-related fatigue. Fatigue makes patients more inclined to terminate their treatment, which influences patient prognosis and survivorship. This study explores the effects of a walking program on fatigue and exercise capacity in women who have undergone breast cancer surgery. This was a randomized control trial study with measures taken 3 times over 5 weeks. Sixty-six women with breast cancer were recruited from a medical center in central Taiwan. The intervention was a moderate-intensity, home-based walking program. The Functional Assessment for Chronic Illness Treatment-Fatigue and distance walked in a 6-minute period, respectively, were used to score the main outcome measures of fatigue and exercise capacity. For those who accepted chemotherapy, fatigue was significantly higher during chemotherapy than after surgery. Although participants in the walking program achieved gradually reduced fatigue and increased exercise capacity, there was no significant difference in fatigue and exercise capacity between the exercise and control groups at any of the three measured times. Nurse collaboration with healthcare providers to promote exercise in the breast cancer population may not only improve the health of post-surgery breast cancer women but also enhance the independent functioning of nurses and advance the nursing profession.

Assessment of early onset of driver fatigue using multimodal fatigue measures in a static simulator

Driver fatigue is an important contributor to road accidents. This paper reports a study that evaluated driver fatigue using multimodal fatigue measures, i.e., surface electromyography (sEMG), electroencephalography (EEG), seat interface pressure, blood pressure, heart rate and oxygen saturation level. Twenty male participants volunteered in this study by performing 60 min of driving on a static simulator. Results from sEMG showed significant physical fatigue (ρ < 0.05) in back and shoulder muscle groups. EEG showed significant (ρ < 0.05) increase of alpha and theta activities and a significant decrease of beta activity during monotonous driving. Results also showed significant change in bilateral pressure distribution on thigh and buttocks region during the study. These findings demonstrate the use of multimodal measures to assess early onset of fatigue. This will help us understand the influence of physical and mental fatigue on driver during monotonous driving.