Quality of life in patients with intermittent claudication

© 2017, The Author(s). Background: Intermittent claudication (IC) is a common condition that causes pain in the lower limbs when walking and has been shown to severely impact the quality of life (QoL) of patients. The QoL is therefore often regarded as an important measure in clinical trials investigating intermittent claudication. To date, no consensus exits on the type of life questionnaire to be used. This review aims to examine the QoL questionnaires used in trials investigating peripheral arterial disease (PAD). Material and methods: A systematic review of randomised clinical trials including a primary analysis of QoL via questionnaire was performed. Trials involving patients with diagnosed PAD were included (either clinically or by questionnaire). Any trial which had QoL as the primary outcome data was included with no limit being placed on the type of questionnaire used. Results: The search yielded a total of 1845 articles of which 31 were deemed appropriate for inclusion in the review. In total, 14 different QoL questionnaires were used across 31 studies. Of the questionnaires 24.06% were missing at least one domain when reported in the results of the study. Mean standard deviation varied widely based on the domain reported, particularly within the SF36. Discussion: Despite previous recommendations for Europewide standardisation of quality of life assessment, to date no such tool exists. This review demonstrated that a number of different questionnaires remain in use, that their completion is often inadequate and that further evidence-based guidelines on QoL assessment are required to guide future research

Effect of supervised exercise on physical function and balance in patients with intermittent claudication

Background The aim of the study was to identify whether a standard supervised exercise programme (SEP) for patients with intermittent claudication improved specific measures of functional performance including balance. Methods A prospective observational study was performed at a single tertiary vascular centre. Patients with symptomatic intermittent claudication (Rutherford grades 1–3) were recruited to the study. Participants were assessed at baseline (before SEP) and 3, 6 and 12 months afterwards for markers of lower-limb ischaemia (treadmill walking distance and ankle : brachial pressure index), physical function (6-min walk, Timed Up and Go test, and Short Physical Performance Battery (SPPB) score), balance impairment using computerized dynamic posturography with the Sensory Organization Test (SOT), and quality of life (VascuQoL and Short Form 36). Results Fifty-one participants underwent SEP, which significantly improved initial treadmill walking distance (P = 0·001). Enrolment in a SEP also resulted in improvements in physical function as determined by 6-min maximum walking distance (P = 0·006), SPPB score (P < 0·001), and some domains of both generic (bodily pain, P = 0·025) and disease-specific (social domain, P = 0·039) quality of life. Significant improvements were also noted in balance, as determined by the SOT (P < 0·001). Conclusion Supervised exercise improves both physical function and balance impairment

Temporary balloon catheter occlusion for control of haemorrhage following penetrating axillary artery injury

Penetrating injuries of the axillary artery are uncommon. Their repair can be difficult in the presence of torrential haemorrhage, which obscures the surgical field. We describe the use of interventional radiology for temporary control of bleeding to facilitate surgical repair in a case of penetrating axillary artery injury

Characterisation of baseline microbiological and host factors in an inception cohort of people with surgical wounds healing by secondary intention reveals circulating IL-6 levels as a potential predictive biomarker of healing [version 1; peer review: awaiting peer review]

Background: More than 2 million people per year are treated for surgical wounds in the UK. Over a quarter of these wounds are estimated to heal by secondary intention (from the “bottom up”) resulting in further complications and requiring increased healthcare resources. Identification of microbiological or host biomarkers that can predict healing outcomes may help to optimize the management of surgical wounds healing by secondary intention. However, the microbial and host factor heterogeneity amongst this diverse population is completely unexplored. Methods: We demonstrate feasibility of determining presence and levels of wound microbes and systemic host factors in an inception cohort of 54 people presenting with surgical wounds healing by secondary intention, who were subsequently followed-up for a period of 12-21 months. We present descriptive statistics for plasma levels of inflammatory, angiogenic cytokines and microRNAs, and we identify a range of wound colonizing microbes. We tentatively explore association with healing aiming to generate hypotheses for future research. Results: We report a potential correlation between poor healing outcomes and elevated interleukin (IL)-6 plasma levels at presentation (ρ=0.13) which requires confirmation. Conclusions: This study demonstrates the degree of biological heterogeneity amongst people with surgical wounds healing by secondary intention and proves the feasibility of embedding a biomarker discovery study in a cohort study in surgical wounds. Our results are essential for designing large biomarker discovery studies to further investigate the potential validity of circulating IL-6 or other factors as novel predictive biomarkers of healing for surgical wounds healing by secondary intention

Identifying the research priorities of healthcare professionals in UK vascular surgery: Modified Delphi approach

Background: The Vascular Research Collaborative was established to develop a national research strategy for patients with vascular disease in the UK. This project aimed to establish national research priorities in this patient group. Methods: A modified Delphi approach, an established method for reaching a consensus opinion among a group of experts in a particular field, was used to survey national multidisciplinary vascular clinical specialists. Two rounds of online surveys were conducted involving the membership of the Vascular Society, Society of Vascular Nurses, Society for Vascular Technology, and the Rouleaux Club (vascular surgical trainees). The first round invited any suggestions for vascular research topics. A steering group then collated and rationalized the suggestions, categorizing them by consensus into pathological topics and research categories, and amalgamating the various questions relating to the same fundamental issue into a single question. The second round involved recirculating these questions to the same participants for priority scoring. Results: Round 1 resulted in 1231 suggested research questions from 481 respondents. Steering group collation and rationalization resulted in 83 questions for ranking in round 2. The second round resulted in a hierarchical list of vascular research priorities. The highest scoring priorities addressed topics related to critical lower-limb ischaemia, diabetic foot disease, amputation, wound healing, carotid plaque morphology, and service organization/delivery. Conclusion: It is anticipated that these results will drive the UK national vascular research agenda for the next 5-10 years. It will facilitate focused development and funding of new research projects in current clinical areas of unmet need where potential impact is greatest

high INtensity Interval Training In pATiEnts with intermittent claudication (INITIATE):a qualitative acceptability study

INTRODUCTION: A novel high-intensity interval training (HIIT) programme has demonstrated feasibility for patients with intermittent claudication (IC). The aim of this study was to explore patient perspectives of the HIIT programme to inform refinement and future research.METHODS: All patients screened and eligible for the 'high intensity interval training in patients with intermittent claudication (INITIATE)' study, were eligible to take part in a semi-structured interview. A convenience subsample of patients was selected from three distinct groups: 1) those who completed the HIIT programme, 2) those who prematurely discontinued the HIIT programme and 3) those who declined the HIIT programme. Interviews considered patients views of the programme and experiences of undertaking and/or being invited to undertake it. Interviews were audio recorded, transcribed verbatim and analysed via thematic analysis.RESULTS: Eleven out of 31 participants who completed the programme and twelve out of 38 decliners were interviewed. No participants who withdrew from the programme agreed to interview. The three key themes were; personal reflections of the programme; programme facilitators and barriers; and perceived benefits. Completers enjoyed taking part, reported symptomatic improvement and would complete it again. Practical and psychological barriers exist, such as transport and motivation. Changes to the programme were suggested.CONCLUSION: Findings support the acceptability of this novel HIIT programme, which in combination with the feasibility findings, suggest that a fully powered randomised controlled trial, comparing HIIT to usual-care supervised exercise programmes is warranted.</p

Patient-reported quality of life factors in vascular surgical wounds healing by secondary intention (SWHSI) : a qualitative patient and public involvement (PPI) exploration

Background: Surgical wounds healing by secondary intention (SWHSI) represent a significant burden to patients and services. An understanding of quality of life factors affecting this population is essential to recognise the impact of this wound entity on patients. Understanding of the patient experience is necessary to building effective services and designing high-quality research studies to improve care in this population. Methods: Twelve individuals with lived experience of living with a SWHSI or caring for a person with a SWHSI were recruited to one of two focus groups. Participants were identified from those who had previously been recruited into the NIHR-funded SWHSI-2 trial (NIHR17/42/94; a study assessing healing of surgical wound healing by secondary intention). All participants in this cohort had lower limb SWHSIs and a history of peripheral vascular disease. Sessions followed a general topic guide and were guided by the research team. Sessions were audio-recorded, transcribed and analysed using thematic analysis methods. Results: Four main areas of impact on quality of life were identified: mental health, physical symptoms, lifestyle symptoms and service-based impacts. There was a clear heterogeneity of experience seen within the group, with some reporting a more significant impact than others. This was ascribed to the loss of social and professional functioning, and the subsequent impact on mental health. There was a differential impact of this on younger participants (who tended to be employed and hold caring roles for children or family members) compared to older participants who did not have these social roles to fulfil, and were less affected in these areas. The need for improved preoperative counselling was highlighted, as many participants reported feeling unprepared for the postoperative course. Conclusions: This study considered the experiences of patients with a SWHSI and identified the main areas of impact on quality of life. This work will help to underpin future research into treatments and services for the SWHSI population. It may also form the basis for identifying an appropriate patient-reported outcome measure (PROM) related to quality of life in SWHSI for use in the research setting. Limitations of the study included the number and diversity of participants, and the impact of the SARS-CoV-2 (COVID-19) pandemic on the experiences of participants. Further exploration of the area through formal qualitative study is warranted to understand the breadth, generalisability and possible future applications of the work

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)