Assessing fatigue in adults with Axial Spondyloarthritis : a systematic review of the quality and acceptability of patient-reported outcome measures

Objective Evaluate the quality and acceptability of patient-reported outcome measures used to assess fatigue in patients with Axial Spondyloarthritis. Methods A two-stage systematic review of major electronic databases (1980-2017) to: 1) Identify measures; and 2) Identify evaluative studies. Study and measurement quality was evaluated following international standards. Measurement content was appraised against a conceptual model of RA-fatigue. Results From 387 reviewed abstracts, 23 articles provided evidence for nine fatigue-specific measures: six multi-item and three single-item. No axSpA-fatigue specific measure was identified. Evidence of reliability was limited, but acceptable for the Multi-dimensional Fatigue Inventory (internal consistency, test-retest) and Short Form 36-item Health Survey Vitality subscale (SF-36 VT) (internal consistency). Evidence of construct validity was moderate for the Functional Assessment of Chronic Illness Therapy-Fatigue and 10cm visual analogue scale, limited for the SF-36 VT, and not available for the remaining measures. Responsiveness was rarely evaluated. Evidence of measurement error, content validity or structural validity was not identified. Most measures provide a limited reflection of fatigue; the most comprehensive were the Multi-dimensional Assessment of Fatigue (MAF), MFI-20, FACIT-fatigue and Fatigue Severity Scale (FSS). Conclusion The limited content and often poor quality of the reviewed measures limits any clear recommendation for fatigue-assessment in this population; assessments should be applied with caution until further robust evidence is established. Well developed, patient-derived measures can provide essential evidence of the patient’s perspective to inform clinical research and drive tailored healthcare. The collaborative engagement of key stakeholders must seek to ensure that future fatigue assessment is relevant, acceptable and of high quality

Assessing health-related quality of life (HRQoL) in survivors of out-of-hospital cardiac arrest : A systematic review of patient-reported outcome measures

Aim: High quality evidence of out-of-hospital cardiac arrest (OHCA) survivors' health-related quality of life (HRQoL) can measure the long-term impact of CA. The aim of this study was to critically appraise the evidence of psychometric quality and acceptability of measures used in the assessment of HRQoL in cardiac arrest survivors. Methods: Systematic literature searches (2004-2017) and named author searches to identify articles pertaining to the measurement of HRQoL. Data on study quality, measurement and practical properties were extracted and assessed against international standards. Results: From 356 reviewed abstracts, 69 articles were assessed in full. 25 provided evidence for 10 measures of HRQoL: one condition-specific; three generic profile measures; two generic index; and four utility measures. Although limited, evidence for measurement validity was strongest for the HUI3 and SF-36. However, evidence for reliability, content validity, responsiveness and interpretability and acceptability was generally limited or not available in the CA population for all measures. Conclusions: This review has demonstrated that a measure of quality of life specific to OHCA survivors is not available. Limited evidence of validity exists for one utility measure - the HUI3 - and a generic profile - the SF-36. Robust evidence of the quality and acceptability of HRQoL measures in OHCA was limited or not available. Future collaborative research must seek to urgently establish the relevance and acceptability of these measures to OHCA survivors, to establish robust evidence of essential measurement and practical properties over the short and long-term, and to inform future HRQoL assessment in the OHCA population. (C) 2017 Elsevier B.V. All rights reserved.Peer reviewe

Climate change modulates the stratospheric volcanic sulfate aerosol lifecycle and radiative forcing from tropical eruptions.

Explosive volcanic eruptions affect climate, but how climate change affects the stratospheric volcanic sulfate aerosol lifecycle and radiative forcing remains unexplored. We combine an eruptive column model with an aerosol-climate model to show that the stratospheric aerosol optical depth perturbation from frequent moderate-magnitude tropical eruptions (e.g. Nabro 2011) will be reduced by 75% in a high-end warming scenario compared to today, a consequence of future tropopause height rise and unchanged eruptive column height. In contrast, global-mean radiative forcing, stratospheric warming and surface cooling from infrequent large-magnitude tropical eruptions (e.g. Mt. Pinatubo 1991) will be exacerbated by 30%, 52 and 15% in the future, respectively. These changes are driven by an aerosol size decrease, mainly caused by the acceleration of the Brewer-Dobson circulation, and an increase in eruptive column height. Quantifying changes in both eruptive column dynamics and aerosol lifecycle is therefore key to assessing the climate response to future eruptions

Co-producing a multi-stakeholder core outcome set for distal tibia and ankle fractures (COSTA) : a study protocol

Background: Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce – with patient partners and other key stakeholders – a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. Methods: The study will have five-stages which will include: i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; v) and an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. Discussion: Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste

A systematic review of outcome reporting in clinical trials of distal tibia and ankle fractures : the need for a core outcome set

Aim: To describe outcome reporting variation and trends in non-pharmacological randomised clinical trials (RCT) of distal tibia and/or ankle fractures. Method: Five electronic databases and three clinical trial registries were searched (January 2000-February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles, and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results: 105 trials (n=16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (62), post-surgical management options (17), rehabilitative interventions (14), surgical versus non-surgical interventions (6), and pre-surgical management strategies (5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion: Substantial heterogeneity in outcome selection, assessment methods and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardisation, that captures the outcomes that matter to multiple stakeholders, is urgently required

Understanding patient experience of distal tibia or ankle fracture : a qualitative systematic review

Aims To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery. Methods We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes. Results From 2,682 records, 15 studies were reviewed in full and four included in the review. A total of 72 patients were included across the four studies (47 female; mean age 50 years (17 to 80)). Methodological quality was high for all studies, and the GRADE-CERQual checklist provided confidence that the findings were an adequate representation of patient experience of distal tibia or ankle fracture. A central concept of ‘being the same but different’ conveyed the substantial disruption to patients’ self-identity caused by their injury. Patient experience of ‘being the same but different’ was expressed through three interrelated themes, with seven subthemes: i) being proactive where persistence, doing things differently and keeping busy prevailed; ii) living with change including symptoms, and living differently due to challenges at work and leisure; and iii) striving for normality, adapting while lacking in confidence, and feeling fearful and concerned about the future. Conclusion Ankle injuries were disruptive, draining, and impacted on patients’ wellbeing. Substantial short- and longer-term challenges were experienced during recovery. Rehabilitation and psychosocial treatment strategies may help to ameliorate these challenges. Patients may benefit from clinicians being cognisant of patient experience when assessing, treating, and discussing expectations and outcomes with patients

Development of the Warwick Axial Spondyloarthritis faTigue and Energy questionnaire (WASTEd) – a new patient-reported outcome measure

Objective To co-produce and test a potential new patient-reported outcome measure (PROM) - the Warwick Axial Spondyloarthritis faTigue and Energy questionnaire (WASTEd), providing vital qualitative confirmation of conceptual relevance, clarity, and acceptability. Methods Informed by measurement theory, we collaborated with patient partners throughout a three-stage, iterative process of PROM development. Stage 1: Informed by patient interviews, reviews exploring patients’ fatigue experiences, and existing PROMs of fatigue, an initial measurement framework of axSpA fatigue and energy and candidate items were defined. Stage 2: The relevance and acceptability of the measurement framework and candidate items were assessed qualitatively by focus group participants. Stage three: Patients participated in pretesting interviews to assess item comprehensiveness, relevance, acceptability, and comprehensibility. Results Stage one informed the development of an initial five-domain measurement framework, with 59 candidate items. In stage two, five patients and seven healthcare professionals participated in four focus groups to derive a 40-item model of fatigue and energy. Collaborative engagement with patient research partners further supported refinement of questionnaire structure and content. Pretesting with ten patients across two interview rounds in stage three produced a four-domain, 30-item long-form questionnaire. Conclusions An active collaboration with patients and healthcare professionals has supported the co-production of a potential new PROM of axSpA fatigue, underpinned by strong evidence of face and content validity. The WASTEd extends the assessment of fatigue beyond severity, highlighting the importance of symptom frequency, energy, and self-management. Future research will involve psychometric evaluation, supporting item-reduction, structural refinement, and confirmation of PROM validity

Qualitative interview study exploring the patient experience of living with axial spondyloarthritis and fatigue : difficult, demanding and draining

Objective: To explore patients’ lived experiences of axial spondyloarthritis (axSpA) and fatigue. Design: Interpretative phenomenological analysis (lived experience) was used as the study design. Analysis drew together codes with similar meaning to create superordinate and subordinate themes. Setting: Rheumatology departments in three National Health Service Foundation Trusts in the north, midlands and south of England. Participants: A purposive sample of seventeen axSpA patients were recruited. The age range was 22–72 years (median age 46), nine were male and eight, female. Results: A central concept of achieving balance was identified as the active process of integrating axSpA symptoms and fatigue into daily life, working with and not against their condition to lead a fulfilled life. This was conveyed through three superordinate themes: struggling to find energy, engaging in everyday life and persevering through difficulties. Struggling to find energy was the challenge of retaining enough stamina to do things in daily life. Engaging in everyday life highlighted dedication to being active and organised, learning through experience and acceptance of a changed way of being. Persevering through difficulties identified the physical and emotional effort required to keep moving forward and the importance of feeling supported. Conclusion: Achieving balance through finding energy, engaging and persevering everyday was fundamental to having the best possible life. The experience of energy emerged as a distinct but related component of fatigue. However, while energy could be maintained or replenished, fatigue was more difficult to overcome and required greater effort. Energy may be a useful indicator of an individual’s current state and ability to sustain activities that supports their well-being, such as exercise. Awareness of the elements of achieving balance in axSpA may enable patients and clinicians to work together to tailor treatments to individual patient need

Does the Degree of Hepatocellular Carcinoma Tumor Necrosis following Transarterial Chemoembolization Impact Patient Survival?

Purpose. The association between transarterial chemoembolization- (TACE-) induced HCC tumor necrosis measured by the modified Response Evaluation Criteria In Solid Tumors (mRECIST) and patient survival is poorly defined. We hypothesize that survival will be superior in HCC patients with increased TACE-induced tumor necrosis. Materials and Methods. TACE interventions were retrospectively reviewed. Tumor response was quantified via dichotomized (responders and nonresponders) and the four defined mRECIST categories. Results. Median survival following TACE was significantly greater in responders compared to nonresponders (20.8 months versus 14.9 months, p=0.011). Survival outcomes also significantly varied among the four mRECIST categories (p=0.0003): complete, 21.4 months; partial, 20.8; stable, 16.8; and progressive, 7.73. Only progressive disease demonstrated significantly worse survival when compared to complete response. Multivariable analysis showed that progressive disease, increasing total tumor diameter, and non-Child-Pugh class A were independent predictors of post-TACE mortality. Conclusions. Both dichotomized (responders and nonresponders) and the four defined mRECIST responses to TACE in patients with HCC were predictive of survival. The main driver of the survival analysis was poor survival in the progressive disease group. Surprisingly, there was small nonsignificant survival benefit between complete, partial, and stable disease groups. These findings may inform HCC treatment decisions following first TACE

Landscape dynamics (landDX) an open-access spatial-temporal database for the Kenya-Tanzania borderlands

The savannas of the Kenya-Tanzania borderland cover >100,000 km2 and is one of the most important regions globally for biodiversity conservation, particularly large mammals. The region also supports >1 million pastoralists and their livestock. In these systems, resources for both large mammals and pastoralists are highly variable in space and time and thus require connected landscapes. However, ongoing fragmentation of (semi-)natural vegetation by smallholder fencing and expansion of agriculture threatens this social-ecological system. Spatial data on fences and agricultural expansion are localized and dispersed among data owners and databases. Here, we synthesized data from several research groups and conservation NGOs and present the first release of the Landscape Dynamics (landDX) spatial-temporal database, covering ~30,000 km2 of southern Kenya. The data includes 31,000 livestock enclosures, nearly 40,000 kilometres of fencing, and 1,500 km2 of agricultural land. We provide caveats and interpretation of the different methodologies used. These data are useful to answer fundamental ecological questions, to quantify the rate of change of ecosystem function and wildlife populations, for conservation and livestock management, and for local and governmental spatial planning.The South Rift Association of Land Owners (specifically grants from the European Union and the Lion Recovery Fund), BigLife Foundation, Esri Conservation Program, Mara Elephant Project, Microsoft AI4Earth programme, the Carlsberg Foundation Semper Ardens project MegaPast2Future, and the VILLUM Investigator project “Biodiversity Dynamics in a Changing World” funded by VILLUM FONDEN, the European Research Council (ERC) project ANTHEA.http://www.nature.com/scientificdataam2023Mammal Research InstituteZoology and Entomolog