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

Peer reviewedPublisher PD

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

Individualised pelvic floor muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial

<br>Background: Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapsed are often advised to do pelvic floor muscle exercises, but supporting evidence is limited. Our aim was to establish if one-to-one individualised pelvic floor muscle training (PFMT) is effective in reducing prolapse symptoms.</br> <br>Methods: A parallel‐group multicentre randomised controlled trial (ISRCTN35911035) in female outpatients with newly-diagnosed, symptomatic stage I, II or III prolapse, comparing five PFMT appointments over 16 weeks (n=225) versus a lifestyle advice leaflet (n=222). Treatment allocation was by remote computer allocation using minimisation. Our primary endpoint was participants’ self-report of prolapsed symptoms at 12 months. Group assignment was masked from outcome assessors. We compared outcomes between trial groups in an intention-to-treat analysis. The cost of PFMT and savings on subsequent treatments were calculated to estimate cost-effectiveness.</br> <br>Findings: Compared to the control group, the intervention group reported fewer prolapse symptoms at 12 months (mean difference between groups in change score 1.52, 95% CI [0.46, 2.59], p=0.0053); reported their prolapse to be “better” more often (57.2% versus 44.7%, difference 12.6%, 95% CI [1.1%, 24.1%], p=0.0336); and had an increased but non-significant odds of having less severe stage of prolapse at their 6-month clinical examination, (OR 1.47, 95% CI [0.97, 2.27], p=0.07). The control group had a greater uptake of other prolapse treatment (49.6% versus 24.1%, difference 25.5%, 95% CI [14.5%, 36.0%], p <0.0001). Findings were robust to missing data. The net cost of the 25 intervention was £131.61 per woman and the cost per one-point reduction in the symptom score was £86.59, 95% CI [£50.81, £286.11]. </br&gt

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

18th-Century Blues: Exploring the Melancholy Mind

'Before Depression' is a three-year research project by the English departments of the Universities of Northumbria and Sunderland and funded by the Leverhulme Trust. This exhibition brings together a range of artists who treated 'the blues' in their work. They include the influential Albrecht Durer, William Hogarth, Joshua Reynolds, George Romney, Joseph Wright, Thomas Rowlandson, William Blake, Maria Cosway, Thomas Jones, Jacob van Ruisdael, Caspar David Friedrich, Charles Le Brun, Johann Caspar Lavater, John Constable, John Martin and local artist Luke Clennell. Some were themselves depressive, some were interested in medical matters connected with the condition, some painted melancholy scenes, some even made fun of 'depression' for satirical purposes, and some painted friends and well-known figures who we know suffered from periodic low spirits. 18th-Century Blues offers a sometimes lively, sometimes sombre but, we hope, always thought-provoking insight into how people dealt with a common human experience two hundred years ago. Works are kindly loaned by The National Gallery, London; Tate; The National Portrait Gallery; The British Museum, London; The Wellcome Library, London; The Whitworth Art Gallery, University of Manchester; Derby Museums and Art Gallery; The Laing Art Gallery, Newcastle upon Tyne (Tyne and Wear Museums); The Hatton Gallery, Newcastle University and Petworth House, The Egremont Collection (acquired in lieu of tax by HM Treasury in 1957 and subsequently transferred to The National Trust)