Long-term outcomes of a randomized clinical trial of supervised exercise, percutaneous transluminal angioplasty or combined treatment for patients with intermittent claudication due to femoropopliteal disease

Background: To compare the long-term outcomes of angioplasty (PTA), supervised exercise (SEP) and combined treatment (PTA+SEP) in patients with intermittent claudication (IC) due to femoropopliteal disease. Methods: Patients recruited to PTA, SEP and PTA+SEP arms of RCT were invited for long-term follow-up from 2010 to 2011.Indicators of limb ischaemia were recorded (ankle-brachial pressure indices, treadmill walking distances (ICD, MWD, PRWD). Duplex ultrasound was also performed. Patients completed SF36 and Vascuqol quality of life(QOL) questionnaires. Results: Of the 178 patients recruited in the trial, 139 were alive at the time of follow-up (PTA=46, SEP=47, PTA+SEP=46). Assessments were completed for 111 patients. Median time to follow-up was 5.2years (IQR 3.8-7.4years). Median age of patients at follow up was 75years. 62.2%(N=69) of patients were symptomatic.16.2%(N= 18) had experienced major cardiovascular event since their last follow-up visit. Intra-group analysis: Improvement was observed in ankle brachial pressure index (ABPI) in all groups. QOL outcomes were inconsistent across individual groups. Inter-group analysis: PTA and PTA+SEP groups demonstrated a significantly higher ABPI as compared to SEP group. No significant difference was observed in walking distances, QOL outcomes, restenosis rates, and new ipsilateral and contralateral lesions on duplex scan. Patients required re-interventions in all group (PTA=14, SEP=10, PTA+SEP=6). Number of re-interventions was higher in PTA group(N=29) as compared to SEP(N=17) and PTA+SEP(N=9) but failed to reach statistical significance. Conclusion: PTA, SEP and combined treatment are equally effective long-term treatment options for patients with femoropopliteal claudication. Addition of SEP to PTA can reduce the symptomatic restenosis and re-intervention rates

Randomized clinical trial of percutaneous transluminalangioplasty, supervised exercise and combined treatment forintermittent claudication due to femoropopliteal arterial disease

Background:The aim was to compare percutaneous transluminal angioplasty (PTA), a supervisedexercise programme (SEP) and combined treatment (PTA plus SEP) for intermittent claudication dueto femoropopliteal arterial disease.Methods: Consenting patients with femoropopliteal arterial lesions were randomized to one of threetreatment arms: PTA, SEP, or PTA plus SEP. All patients received optimal medical treatment. Patientswere assessed at baseline and 1, 3, 6 and 12 months after intervention. Clinical (ankle pressures, walkingdistances, symptoms) and quality-of-life (QoL) outcomes (Short Form 36, VascuQol) were analysed.Results: A total of 178 patients (108 men, median age 70 years) were included. All three treatmentgroups demonstrated significant clinical and QoL improvements. One year after PTA (60 patients, 8withdrew), 37 patients (71 per cent) had improved (16 mild, 16 moderate, 5 marked), nine (17 per cent)showed no improvement and six (12 per cent) had deteriorated. After SEP (60 patients, 14 withdrew),32 patients (70 per cent) had improved (19 mild, 10 moderate, 3 marked), six (13 per cent) showed noimprovement and eight (17 per cent) had deteriorated. After PTA plus SEP (58 patients, 11 withdrew),40 patients (85 per cent) had improved (18 mild, 20 moderate, 2 marked), seven (15 per cent) showedno improvement and none had deteriorated. On intergroup analysis, PTA and SEP alone were equallyeffective in improving clinical outcomes, although the effect was short-lived. PTA plus SEP produced amore sustained clinical improvement, but there was no significant QoL advantage.Conclusion: For patients with intermittent claudication due to femoropopliteal disease, PTA, SEP,and PTA plus SEP were all equally effective in improving walking distance and QoL after 12 months.Registration number: NCT00798850 (http://www.clinicaltrials.gov)

Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial - THRIVE trial

\ua9 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.Introduction Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. Methods and analysis A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. Ethics and dissemination Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. Trial registration number ISRCTN18501431

Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK:a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective.METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences.TRIAL REGISTRATION NUMBER: ISRCTN18501431.</p

"I could cry, the amount of shoes I can't get into": A qualitative exploration of the factors that influence retail footwear selection in women with rheumatoid arthritis

<p>Abstract</p> <p>Background</p> <p>Studies have reported that women with rheumatoid arthritis (RA) are not wearing NHS supplied therapeutic footwear; therefore it is likely they are wearing footwear sourced through retailers. Previous research gives limited information (largely associated with cosmesis) on people's perceptions on the relationships that exist between retail footwear, well-being and quality of life. This study aimed to explore the perceptions of women with RA regarding their choice of retail footwear and identify the factors influencing retail footwear selection.</p> <p>Methods</p> <p>Eleven women with RA wearing normal retail footwear were recruited from an out-patient podiatry clinic in the south east of England. Semi-structured interviews were carried out and an interpretative phenomenological approach was adopted for data collection and transcript analysis.</p> <p>Results</p> <p>Six key themes were revealed from the analysis: (1) the nature of foot complaints and deformities, (2) aesthetic appearance and design of footwear, (3) body image, (4) psychosocial aspects, (5) Perceptions of footwear and (6) the therapeutic value of retail shoes. These contributed to an overarching concept of loss of choice associated with retail footwear. In particular, the areas discussed most frequently throughout were themes (2), (3) and (4), which were notably more 'emotional' in nature.</p> <p>Conclusions</p> <p>Limitations in retail footwear for these women have impacted on their individuality, linking significantly with their body image. The loss of choice in footwear as a consequence of the disease impacts negatively on emotions, wellbeing and was identified in reduced self-perceived quality of life.</p

Delivering cognitive analytic consultancy to community mental health teams: Initial practice-based evidence from a multi-site evaluation.

Objectives: This study sought to employ the hourglass model to frame the methodological evolution of outcome studies concerning 5-session cognitive analytic consultancy (CAC). Design: Pre-post mixed methods evaluation (study one) and mixed methods case series (study two). Methods: In study one, three sites generated acceptability and pre-post effectiveness outcomes from N = 58 care dyads, supplemented with qualitative interviewing. The client outcome measures included the Clinical Outcomes in Routine Evaluation Outcome Measure, Personality Structure Questionnaire, Work and Social Adjustment Questionnaire, Service Engagement Scale, and the Working Alliance Inventory. Study two was a mixed methods case series (N = 5) using an A/B phase design with a 6-week follow-up. Client outcome measures were the Personality Structure Questionnaire, Clinical Outcomes in Routine Evaluation Outcome Measure, and the Working Alliance Inventory, and the staff outcome measures were the Working Alliance Inventory, Maslach Burnout Inventory, and the Perceived Competence Scale. Results: In study one, the cross-site dropout rate from CAC was 28.40% (the completion rate varied from 58 to 100%) and full CAC attendance rates ranged from 61 to 100%. Significant reductions in client distress were observed at two sites. Qualitative themes highlighted increased awareness and understanding across care dyads. In study two, there was zero dropout and full attendance. Clients were significantly less fragmented, and staff felt significantly more competent and less exhausted. Potential mechanisms of change were the effective process skills of the consultant and that emotionally difficult CAC processes were helpful. Conclusions: Cognitive analytic consultancy appears a promising approach to staff consultation, and testing in a clinical trial is now indicated. Practitioner Points: CAC is a suitable method of consultation for care dyads struggling to work effectively together in CMHTs. Staff feel more competent and clients feel less fragmented following CAC, and the benefits of CAC appear to be maintained over follow-up time. CAC processes can be difficult for care coordinator and client, but this is not an impediment to change

Live Imaging of Innate Immune Cell Sensing of Transformed Cells in Zebrafish Larvae: Parallels between Tumor Initiation and Wound Inflammation

Live imaging and genetic studies of the initial interactions between leukocytes and transformed cells in zebrafish larvae indicate an attractant role for H2O2 and suggest that blocking these early interactions reduces expansion of transformed cell clones