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

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

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)

Nurses' and surgeons' views and experiences of surgical wounds healing by secondary intention : a qualitative study

AIMS AND OBJECTIVES: To explore surgeons' and nurses' perspectives of managing surgical wounds healing by secondary intention. BACKGROUND: Every year, more than 10 million surgical operations are performed in the NHS in the UK. Most surgical wounds heal by primary intention, where the edges of the wound are brought together with staples, sutures, adhesive glue or clips. Sometimes wounds are deliberately left open to heal, from the base up, known as 'healing by secondary intention'. These wounds are often slow to heal, prone to infection, and complex to manage. DESIGN: A qualitative, descriptive approach, using semi-structured interviews. METHODS: Interviews with five (general, vascular and plastic) surgeons and 7 nurses (3 tissue viability nurses, 2 district and 1 community nurse, and 1 hospital nurse) working in hospital and community care settings in two locations in the north of England. Data analysis followed the recommended sequential steps of 'Framework' approach. Consolidated criteria for reporting qualitative research guided the study report. RESULTS: Participants reported that the main types of wounds healing by secondary intention that they manage are extensive abdominal cavity wounds; open wounds relating to treatment for pilonidal sinus; large open wounds on the feet of patients with diabetes; and axilla and groin wounds, associated with removal of lymph nodes for cancer. Infection and prolonged time to healing were the main challenges. Negative pressure wound therapy was the most favoured treatment option. CONCLUSIONS: Negative pressure wound therapy was advocated by professionals despite a lack of research evidence indicating clinical or cost-effectiveness. Our findings underscore the need for rigorous evaluation of negative pressure wound therapy, and other wound care treatments, through studies that include economic evaluation. RELEVANCE FOR CLINICAL PRACTICE: Clinical decision making in wound care could be optimised through further robust studies to inform practitioners about the cost-effectiveness of available treatments

Pilot feasibility randomized clinical trial of negative-pressure wound therapy versus usual care in patients with surgical wounds healing by secondary intention

Background Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative‐pressure wound therapy (NPWT) despite a lack of high‐quality research evidence regarding its clinical and cost‐effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI. Methods Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1–2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed. Results A total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty‐four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0–72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study. Conclusion A full‐scale RCT to investigate the clinical and cost‐effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (www.iscrtn.com

A randomized trial comparing treatments for varicose veins

Supported by a grant from the Health Technology Assessment Programme of the National Institute for Health Research (06/45/02). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorate. We thank Janice Cruden for her secretarial support and data management; Gladys McPherson and the programming team at the Centre for Healthcare Randomised Trials; Tracey Davidson, Lynda Constable, Jackie Ellington, Laura Elliott, and Yvonne Fernie for help with scoring the Aberdeen Varicose Vein Questionnaire; Luke Vale and Laura Ternent, our original economists in the group; members of the Project Management Group for their ongoing advice and support of the trial; members of the study team (Graeme MacLennan, Maria Prior, and Denise Bolsover) who contributed to the behavioral recovery component of the trial; the independent members of the trial steering committee (Alun Davies [chair], Ian Loftus, and Jane Nixon) and the data and safety monitoring committee (Gerry Stansby [chair], Winston Banya, and Marcus Flather); and the staff members at recruitment sites (see the Supplementary Appendix) who facilitated recruitment, treatment, and follow-up of trial participants.Peer reviewedPublisher PD