Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings

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Patients’ and clinicians’ perspectives on the clinical utility of the Rheumatoid Arthritis Foot Disease Activity Index

Although patient-reported outcome measures (PROMs) are recommended in clinical practice, their application in routine care is limited. The Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5) is a validated PROM for assessing foot disease in rheumatoid arthritis (RA). To explore patient and clinician opinions and perceptions of the clinical utility of the Rheumatoid Arthritis Foot Disease Activity Index (RADAI-F5), eight RA patients and eight clinicians routinely involved in the management of RA patients participated in one semi-structured remote video-based interview. They provided their perspectives on the barriers and facilitators to clinical implementation of the RADAI-F5. Three global themes were identified; 'Feet are a priority' as the impact of RA on the feet negatively impacted upon patient quality of life. The second theme was 'Need for a clinically feasible foot PROM' as participants recognised the current lack of a clinically feasible tool to determine RA foot disease. The third global theme of ‘Implementation’ was drawn together to form two subordinate themes: ‘Facilitators to RADAI-F5 implementation’ as the tool can promote communication, guide management, help screen foot symptoms, monitor foot disease status and treatments, and promote patient education and; ‘Barriers to RADAI-F5 implementation’ as there were associated practical difficulties, including lack of appointment time, administrative burdens, IT barriers and preference for further RADAI-F5 validation using imaging. The RADAI-F5 has significant potential as a clinical tool to aid foot disease management. However, implementation challenges must be overcome before broad adoption in rheumatology clinics. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00296-022-05147-8

Can patient characteristics explain variance in ultrasound strain elastography measures of the quadratus femoris and patellar tendons?

Objectives To explore the associations between participant characteristics and magnitudes of difference in paired elastography measures of knee tendon from different ultrasound systems, and to compare strain elastography pattern description. Materials and Methods Quadriceps and patellar tendons of 20 healthy volunteers (40 tendons) were examined by an experienced operator employing two ultrasound systems (GE S8 and Esaote MyLab 70XVG). Pearson/Spearman correlations explored the influence of participant characteristics (BMI, body fat %, leg circumference, activity level) on the magnitude of differences between measures. Paired-sample t test or Wilcoxon signed rank test were performed to compare repeated measures of individual ultrasound systems. Results The quadriceps tendon was characteristically stiffer than the patellar tendon. Participant characteristics were associated with within machine differences of the distal quadriceps tendon (BMI; r = 0.49, p = 0.028–0.03 and body fat %; r = 0.43, p = 0.05–0.056) ER measures. Conclusions Anthropometric and body composition parameters were associated with within machine differences for elasticity measures, where high BMI and body fat % contribute to paired measurement variance at the distal quadriceps tendon. Strain elastography protocols should be standardised, repeated ER measures performed using the same US system and patient characteristics considered for future clinical applications

Intermachine variation of ultrasound strain elastographic measures of the quadriceps and patellar tendons in healthy participants

ObjectivesTo evaluate intermachine variation and compare intraoperator and interoperator agreement and repeatability characteristics of 2 ultrasound (US) systems for measurements of quadriceps and patellar tendons by strain elastography (SE).MethodsForty tendons from 20 healthy participants were investigated by operators with different experience (operator 1, 12 years of US experience and >50 SE examinations; operator 2, no US experience and 1 day of SE training). Repeated measures were performed on GE Healthcare (Waukesha, WI) and Esaote (Genoa, Italy) US systems. The percentage of agreement, Cohen κ, intraclass correlation coefficient, and correlation tests assessed agreement, repeatability, and associations of SE measures. A paired t test and Wilcoxon signed rank test assessed differences in SE measures. ResultsThe study participants included 5 male and 15 female volunteers (mean [range] age, 29.3 [21–39] years). Better agreement and repeatability characteristics were observed for the patellar compared to the quadriceps tendon and the color score (CS) method over the elasticity ratio (ER). Intraoperator agreement was better for the experienced operator. Intraoperator repeatability was achieved in 55% of ER (intraclass correlation coefficient, 0.40–0.91; P  [less than] .05) and 77% to 85% (κ = –0.25–1) of CS measures. Interoperator repeatability was achieved in 35% (t /z , –2.93–7.94; P  [less than] .001–.048) of all ER measures. No significant differences in proximal (z , –0.13– –0.78) and distal patellar (z , –1.52–2.26; P  > .5) patellar ER measures were observed. Seventy‐four percent to 75% mean agreement (κ = 0–0.5) for CS measures comparable across both US systems was observed. Intermachine ER associations were poor (r = –0.39–0.13; P  > .05), whereas greater than 70% agreement (κ = –0.87–0.53) for the CS was achieved. ConclusionsThe reproducibility of knee tendon SE measurements is influenced by the operator experience, US system, and tendon site

Strain sonoelastography in asymptomatic individuals and individuals with knee osteoarthritis: an evaluation of quadriceps and patellar tendon

An advanced ultrasound imaging technique, sonoelastography (SE) is used to evaluate tissue elasticity. To determine SE potential to detect pathological-related changes, and characteristics related to tendon pathology we aimed to (1) compare quadriceps and patellar tendon findings in individuals with knee osteoarthritis (KOA) and asymptomatic older adults (AC), and (2) explore associations between SE, participant characteristics (age, BMI, and leg circumference) and KOA status. 84 participants (47; KOA and 37; asymptomatic older adults) underwent SE examination of quadriceps (distal) and patellar (distal, proximal) tendon in a supine position with the knee bent at 30°. Colour score (CS) and Elasticity Ratio (ER) analysis were performed by a blinded experienced operator using Esaote Mylab 70 XVG Ultrasound equipment. Significantly reduced elasticity in the distal quadriceps (median (IQR) 2(2), 3(1), p = 0.033 for KOA and AC, respectively) and proximal patellar (3(1), 3(0), p = 0.001) tendons and more elastic distal patellar (1.50 (0.55), 1.87 (0.72), p = 0.034) tendons were observed in the KOA group. Significant associations) were identified between SE and participant BMI (Rs = − 0.249–0.750, p < 0.05) and leg circumference (Rs = − 0.260–0.903, p < 0.05). Age, BMI and KOA status, were independent explanatory variables of SE CS findings at the distal quadriceps tendon patellar tendon, proximal patellar tendon and distal patellar tendon, explaining 66%, 81% and 64% of variance, respectively. Age, BMI and KOA status were independent explanatory variables of SE ER findings at the distal patellar tendon explaining 19% of variance. Potentially clinically relevant altered tendon stiffness were observed between individuals with KOA and asymptomatic controls. Key KOA risk factors and participant characteristics explained variance in tendon stiffness. Findings provide context for future studies to investigate the potential for targeted SE detected early clinical management based on associated participant characteristics

The Sleep/Wake Cycle is Directly Modulated by Changes in Energy Balance.

STUDY OBJECTIVES: The rise in obesity has been paralleled by a decline in sleep duration in epidemiological studies. However, the potential mechanisms linking energy balance and the sleep/wake cycle are not well understood. We aimed to examine the effects of manipulating energy balance on the sleep/wake cycle. METHODS: Twelve healthy normal weight men were housed in a clinical research facility and studied at three time points: baseline, after energy balance was disrupted by 2 days of caloric restriction to 10% of energy requirements, and after energy balance was restored by 2 days of ad libitum/free feeding. Sleep architecture, duration of sleep stages, and sleep-associated respiratory parameters were measured by polysomnography. RESULTS: Two days of caloric restriction significantly increased the duration of deep (stage 4) sleep (16.8% to 21.7% of total sleep time; P = 0.03); an effect which was entirely reversed upon free feeding (P = 0.01). Although the apnea-hypopnea index stayed within the reference range (< 5 events per hour), it decreased significantly from caloric restriction to free feeding (P = 0.03). Caloric restriction was associated with a marked fall in leptin (P < 0.001) and insulin levels (P = 0.002). The fall in orexin levels from baseline to caloric restriction correlated positively with duration of stage 4 sleep (Spearman rho = 0.83, P = 0.01) and negatively with the number of awakenings in caloric restriction (Spearman rho = -0.79, P = 0.01). CONCLUSIONS: We demonstrate that changes in energy homeostasis directly and reversibly impact on the sleep/wake cycle. These findings provide a mechanistic framework for investigating the association between sleep duration and obesity risk.Wellcome Trust, National Institute for Health Research Cambridge Biomedical Research Centre, European Research Council, Bernard Wolfe Health Neuroscience Fund, Swiss National Science Foundation (Grant IDs: PBLAP3-145870, P3SMP3-155318), European Society of Endocrinology (Grant ID: IESP), German Research Foundation (Grant ID: TR-SFB 654, B01), NeuroFAST consortium which is funded by the European Union’s Seventh Framework Programme (FP7/2007-2013) (Grant ID: 245009)This is the author accepted manuscript. The final version is available from the Associated Professional Sleep Societies, LLC via http://dx.doi.org/10.5665/sleep.609

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Generic health literacy measurement instruments for children and adolescents:a systematic review of the literature

Background Health literacy is an important health promotion concern and recently children and adolescents have been the focus of increased academic attention. To assess the health literacy of this population, researchers have been focussing on developing instruments to measure their health literacy. Compared to the wider availability of instruments for adults, only a few tools are known for younger age groups. The objective of this study is to systematically review the field of generic child and adolescent health literacy measurement instruments that are currently available. Method A systematic literature search was undertaken in five databases (PubMed, CINAHL, PsycNET, ERIC, and FIS) on articles published between January 1990 and July 2015, addressing children and adolescents ?18 years old. Eligible articles were analysed, data was extracted, and synthesised according to review objectives. Results Fifteen generic health literacy measurement instruments for children and adolescents were identified. All, except two, are self-administered instruments. Seven are objective measures (performance-based tests), seven are subjective measures (self-reporting), and one uses a mixed-method measurement. Most instruments applied a broad and multidimensional understanding of health literacy. The instruments were developed in eight different countries, with most tools originating in the United States (n =?6). Among the instruments, 31 different components related to health literacy were identified. Accordingly, the studies exhibit a variety of implicit or explicit conceptual and operational definitions, and most instruments have been used in schools and other educational contexts. While the youngest age group studied was 7-year-old children within a parent-child study, there is only one instrument specifically designed for primary school children and none for early years. Conclusions Despite the reported paucity of health literacy research involving children and adolescents, an unexpected number of health literacy measurement studies in children?s populations was found. Most instruments tend to measure their own specific understanding of health literacy and not all provide sufficient conceptual information. To advance health literacy instruments, a much more standardised approach is necessary including improved reporting on the development and validation processes. Further research is required to improve health literacy instruments for children and adolescents and to provide knowledge to inform effective interventionspublishersversionPeer reviewe