Service user and community clinician design of a partially virtual diabetic service improves access to care and education and reduces amputation incidence.

INTRODUCTION: Design of an integrated diabetes service based on needs of service users (persons living with diabetes) and community clinicians in a semirural low-income health district of the UK. RESEARCH DESIGN AND METHODS: One hundred and eighty-five service users engaged through public meetings, questionnaires and focus groups. General practice staff contributed views through workshops and questionnaires. Analysis of feedback indicated service user needs for better access to education, dietary advice and foot care. General practice staff endorsed these views and requested regular access to secondary care in the community. Seven hundred persons registered with diabetes attended eight well-being events in the community. From 2017 virtual practice multidisciplinary patient reviews, virtual referral of foot cases and non-face-to-face helplines were developed. A National Health Service (NHS) approved 'App' and web-based personalized education support for those recently diagnosed with diabetes was introduced. RESULTS: Engagement in education for those recently diagnosed with diabetes increased from 5% to 71%. Weight and hemoglobin A1c (HbA1c) levels before and 6 months after starting the program were 99.4±25 and 95.5±24.2 kg and 59.3±16 and 54.8±12.9 mmol/mol, respectively, p=0.00003 and 0.003. Of those engaging at well-being events, 44 had missed regular follow-up. One hundred and seventy-five cases were reviewed virtually with practice staff by the secondary care team avoiding referral to the hospital diabetic clinic. One hundred and seventy-six referrals were made to the virtual multidisciplinary diabetic foot team clinic. Major amputation incidence declined from 13 to 3 major procedures/10 000 per annum and minor amputation from 26 to 18/10 000. Percentage bed day occupancy by persons with diabetes fell significantly in the district general hospital. CONCLUSIONS: Integrated community-based diabetes care delivery has been achieved with partially virtual reviews. Patient education, secondary care in the community, access to dietetic advice and foot care outcomes have all improved.

Ultrasound-guided foam sclerotherapy is a safe and clinically effective treatment for superficial venous reflux.

OBJECTIVE: To test the hypothesis that ultrasound-guided foam sclerotherapy (UGFS) is a safe and durable treatment for superficial venous reflux (SVR) associated with CEAP clinical grade 2-6 disease. METHODS: This was an interrogation of a prospectively gathered computerized database. RESULTS: Between March 23, 2004 and December 31, 2009, 977 patients (1252 legs) underwent UGFS for unilateral (702 legs) or bilateral (550 legs) SVR in association with CEAP clinical grade 2-3 (n = 868), 4 (n = 232), or 5/6 (n = 152) disease. The following reflux in 1417 venous segments was treated: primary great saphenous vein (GSV) (n = 745); recurrent GSV (n = 286), primary small saphenous vein (SSV) (n = 189), recurrent SSV (n = 50); primary anterior accessory saphenous vein (AASV) (n = 93); recurrent AASV (n = 46); vein of the popliteal fossa (VOPF) (n = 5), and Giacomini vein (GV) (n = 3). Three hundred forty-eight legs (27.8%) had undergone previous surgery. Three patients suffered post-UGFS deep vein thrombosis (DVT) and one a pulmonary embolus (PE), all within the first month (0.4% venous thrombo-embolic complication rate). Five patients (0.5%) had transient visual disturbance at the time of, or shortly after, treatment. No other neurologic or serious complications were reported. During a mean (range) follow-up of 28 (<1 to 68) months, 161 (12.9%) legs underwent a further session of UGFS for truncal VV at a mean (range) of 17 (<1 to 63) months following the first treatment. In 52 legs, retreatment was due to the development of new SVR and in 109 legs was for true recurrence (8.7% complete or partial recanalization rate leading to treatment). There was no significant difference in retreatment rates between UGFS for GSV and SSV reflux or between UGFS for primary or recurrent disease. CONCLUSION: UGFS for CEAP 2-6 SVR is associated with a low complication and retreatment rate. However, as patients are at risk of developing recurrent and new SVR they should be kept under review. Further UGFS for new or recurrent disease is simple, safe, and effective.

Changes in health-related quality of life after ultrasound-guided foam sclerotherapy for great and small saphenous varicose veins.

BACKGROUND: Health-related quality of life (HRQOL) improves after superficial venous surgery for varicose veins, but the effect of ultrasound-guided foam sclerotherapy on HRQOL is unknown. The aim of this study was to determine changes in HRQOL after ultrasound-guided foam sclerotherapy for varicose veins. METHODS: Consecutive patients undergoing ultrasound-guided foam sclerotherapy for varicose veins were sent the Short Form 12 (SF-12) questionnaire, a generic measure of HRQOL, and the Aberdeen Varicose Vein Symptom Score (AVSS) questionnaire, a disease-specific measure of HRQOL, 1 week before treatment and 1, 6, and 12 months after treatment. RESULTS: The study enrolled 296 patients (34% male; 395 treated legs) with a median age of 57 years (range, 22-89 years). Of these, 24% had had previous superficial venous surgery, and 66% were CEAP C(2-3) (uncomplicated varicose veins). Questionnaire completion rates were 82%, 73%, and 69% at 1, 6, and 12 months after treatment. The median Physical Component Summary score of the SF-12 (higher score indicates better HRQOL) improved from 47.6 pretreatment to 49.4 at 1 month (P < .008, Wilcoxon signed rank test), to 51.9 at 6 months (P < .0005), and to 52.9 at 12 months (P < .0005). The median AVSS (lower score indicates better HRQOL) improved from 19.0 pretreatment to 16.5 at 1 month (P < .0005), to 8.7 at 6 months (P < .0005), and to 8.6 at 12 months (P < .0005). CONCLUSIONS: Ultrasound-guided foam sclerotherapy for great and small saphenous varicose veins leads to significant improvements in generic and disease-specific HRQOL for at least 12 months after treatment.

Higher prevalence of thrombophilia in patients with varicose veins and venous ulcers than controls.

BACKGROUND: Uncontrolled studies suggest that patients with chronic venous ulceration (CVU) have an increased prevalence of thrombophilia, similar to that observed in patients with deep vein thrombosis. This study compared the nature and prevalence of thrombophilia in patients with varicose veins (VV, CEAP clinical [C] grade C(2) to C(3)) and patients with CVU (C(5) to C(6)) with an age- and sex-matched population without clinical or duplex ultrasound evidence of venous disease. METHODS: Twenty-seven patients with VV, 27 patients with CVU, and 54 age- and sex-matched case controls with no clinical or duplex evidence of lower limb venous disease, underwent testing for factor V Leiden and prothrombin 20210A mutations, antithrombin deficiencies, and levels of antiphospholipid antibodies, homocysteine, protein C and S, and factor VIII, IX, and XI. RESULTS: The overall prevalences of single and multiple thrombophilias were significantly higher in cases than in controls. Specifically, in VV patients, the prevalences of no, single, and multiple thrombophilias were 33%, 52%, and 15%, respectively, compared with 63%, 26%, and 11% in VV controls. In CVU patients, the prevalences of no, single, and multiple thrombophilias was 26%, 30%, and 44%, respectively, compared with 66%, 22%, and 11% in CVU controls. Compared with controls, only factor XI levels were significantly higher in VV patients, and homocysteine and factor VIII, IX, and XI levels were all significantly higher in CVU patients. CONCLUSION: Patients with VV, and particularly CVU, have significantly higher prevalences of single and multiple thrombophilias than age- and sex-matched controls without clinical or duplex evidence of lower limb venous disease. These data support the hypothesis that thrombophilia predisposes to the development of superficial and deep lower limb venous reflux, and so VV and CVU, through the increased occurrence of clinical and subclinical thrombosis.

Impact of UK NICE clinical guidelines 168 on referrals to a specialist academic leg ulcer service.

Background Leg ulcers are a common cause of morbidity and disability and result in significant health and social care expenditure. The UK National Institute for Health and Care Excellence (NICE) Clinical Guideline (CG)168, published in July 2013, sought to improve care of patients with leg ulcers, recommending that patients with a break in the skin below the knee that had not healed within two weeks be referred to a specialist vascular service for diagnosis and management. Aim Determine the impact of CG168 on referrals to a leg ulcer service. Methods Patients referred with leg ulceration during an 18-month period prior to CG168 (January 2012-June 2013) and an 18-month period commencing six months after (January 2014-June 2015) publication of CG168 were compared. Results There was a two-fold increase in referrals (181 patients, 220 legs vs. 385 patients, 453 legs) but no change in mean age, gender or median-duration of ulcer at referral (16.6 vs. 16.2 weeks). Mean-time from referral to specialist appointment increased (4.8 vs. 6 weeks, p = 0.0001), as did legs with superficial venous insufficiency (SVI) (36% vs. 44%, p = 0.05). There was a trend towards more SVI endovenous interventions (32% vs. 39%, p = 0.271) with an increase in endothermal (2 vs. 32 legs, p = 0.001) but no change in sclerotherapy (24 vs. 51 legs) treatments. In both groups, 62% legs had compression. There was a reduction in legs treated conservatively with simple dressings (26% vs. 15%, p = 0.0006). Conclusions Since CG168, there has been a considerable increase in leg ulcer referrals. However, patients are still not referred until ulceration has been present for many months. Although many ulcers are multi-factorial and the mainstay of treatment remains compression, there has been an increase in SVI endovenous intervention. Further efforts are required to persuade community practitioners to refer patients earlier, to educate patients and encourage further investment in chronically underfunded leg ulcer services.

A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins.

OBJECTIVE: The last 10 years have seen the introduction into everyday clinical practice of a wide range of novel non-surgical treatments for varicose veins. In July 2013, the UK National Institute for Health and Care Excellence recommended the following treatment hierarchy for varicose veins: endothermal ablation, ultrasound-guided foam sclerotherapy, surgery and compression hosiery. The aim of this paper is to review the randomised controlled trials that have compared endothermal ablation and ultrasound-guided foam sclerotherapy to determine if the level 1 evidence base still supports an "endothermal ablation first" strategy for the treatment of varicose veins. METHODS: A PubMed and OVID literature search (until 31 January 2015) was performed and randomised controlled trials comparing endothermal ablation and ultrasound-guided foam sclerotherapy were obtained. RESULTS: Although anatomical success appeared higher with endothermal ablation than ultrasound-guided foam sclerotherapy, clinical success and patient-reported outcomes measures were similar. Morbidity and complication rates were very low and not significantly different between endothermal ablation and ultrasound-guided foam sclerotherapy. Ultrasound-guided foam sclerotherapy was consistently less expensive that endothermal ablation. CONCLUSIONS: All endovenous modalities appear to be successful and have a role in modern day practice. Although further work is required to optimise ultrasound-guided foam sclerotherapy technique to maximise anatomical success and minimise retreatment, the present level 1 evidence base shows there is no significant difference in clinical important outcomes between ultrasound-guided foam sclerotherapy and endothermal ablation. As ultrasound-guided foam sclerotherapy is less expensive, it is likely to be a more cost-effective option in most patients in most healthcare settings. Strict adherence to the treatment hierarchy recommended by National Institute for Health and Care Excellence seems unjustified.

The impact of 2013 UK NICE guidelines on the management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK.

OBJECTIVE: Although varicose veins are a common cause of morbidity, the UK National Health Service and private medical insurers have previously sought to ration their treatment in a non-evidence based manner in order to limit health-care expenditure and reimbursement. In July 2013, the UK National Institute for Health and Care Excellence published new national Clinical Guidelines (CG168) to promote evidence-based commissioning and management of varicose veins. The aim of this study was to evaluate the impact of CG168 on the referral and management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK. METHODS: Interrogation of a prospectively gathered database, provided by the Heart of England NHS Foundation Trust Performance Unit, of patients undergoing interventions for varicose veins since 1 January 2012. Patients treated before (group 1) and after (group 2) publication of CG168 were compared. RESULTS: There were 253 patients, 286 legs (48% male, mean (range) age 54 (20-91) years) treated in group 1, and 417 patients, 452 legs, (46% male, mean (range) age 54 (14-90) years) treated in group 2, an increase of 65%. CG168 was associated with a significant reduction in the use of surgery (131 patients (52%) group 1 vs. 127 patients (30%) group 2, p = 0.0003, χ(2)), no change in endothermal ablation (30 patients (12%) group 1 vs. 45 patients (11%) group 2), a significant increase in ultrasound-guided foam sclerotherapy (92 patients (36%) group 1 and 245 patients (59%) group 2, p = 0.0001, χ(2)) and an increase in treatment for C2/3 disease (53% group 1 and 65.2% group 2, p = 0.0022, χ(2)). CONCLUSIONS: Publication of National Institute for Health and Care Excellence CG168 has been associated with a significant increase (65%) in the number of patients treated, referral at an earlier (CEAP C) stage and increased use of endovenous treatment. CG 168 has been highly effective in improving access to, and quality of care, for varicose veins at Heart of England NHS Foundation Trust.

Digital venous photoplethysmography in the seated position is a reproducible noninvasive measure of lower limb venous function in patients with isolated superficial venous reflux.

BACKGROUND: The value of photoplethysmography (PPG) has been questioned because of a lack of reproducibility. We performed this study to determine whether new digital technology has improved the reproducibility of PPG in the noninvasive assessment of lower limb venous function in patients with isolated superficial venous reflux. METHODS: This was a prospective study of 140 legs in 110 patients (65% female; median age [interquartile range], 45 years [36-59.25 years]; CEAP clinical grade C2/3, n = 114; C4-6, n = 26) who underwent repeated digital PPG measurements of refilling time (RT) in both the sitting and standing position after standard exercise regimens by a single observer. RT was measured in all patients 2 to 5 minutes apart and in a randomly selected subgroup of 30 patients (38 limbs) 1 to 2 weeks apart. RT variability was assessed by using Bland and Altman's coefficient of repeatability (CR-RT), where the CR-RT was 1.96 times the standard deviation of the mean difference in RT between two tests. Venous duplex scanning of both the deep and superficial veins was also performed, and a reverse flow of greater than 0.5 seconds was considered abnormal. Only patients with isolated superficial venous reflux were included in the study. RESULTS: The CR-RT of the tests on 140 limbs performed 2 to 5 minutes apart was 10 seconds overall, 3 seconds for RT up to 10 seconds, and 16 seconds for RT between 20 and 40 seconds. The CR-RT of the 38 tests performed 1 to 2 weeks apart was also 10 seconds. No systematic variation due to a nonrandom error was found between the measurements performed either 2 to 5 minutes or 1 to 2 weeks apart. CONCLUSIONS: Digital PPG performed in the seated position in patients with isolated superficial venous reflux provides a reproducible method for the noninvasive assessment of lower limb venous function for both clinical and research purposes. However, the variation in precision of RT with the magnitude of the measurement must be taken into account when results are interpreted in individual patients.

A comparison of the changes in generic quality of life after superficial venous surgery with those after laparoscopic cholecystectomy.

BACKGROUND: Superficial venous surgery (SVS) results in a significant improvement in generic health-related quality of life (HRQL). However, it is unclear how this improvement compares with that observed after other commonly performed general and vascular operations. The aim of this study was to compare the changes in generic HRQL observed before and after SVS for CEAP clinical grade 2 to 4 venous disease with those observed before and after elective laparoscopic cholecystectomy (ELC) for biliary colic. METHODS: The Short Form 12 questionnaire was mailed to patients before and 3, 6, and 12 months after SVS (n = 143) and ELC (n = 60). The responses were used to calculate physical (PCS) and mental (MCS) component summary scores at each time point. A higher score indicates a better HRQL. RESULTS: Before surgery and 3 and 12 months after surgery, patients in the ELC group had a significantly lower PCS than those in the SVS group (40.2 vs 49.5, 48.9 vs 53.1, and 45.4 vs 53.8; P < .001, P = .033, and P < .001, respectively; Mann-Whitney U test). However, the change in PCS observed over the first 12 postoperative months was not significantly different between the SVS and ELC groups. Patients in the ELC group had a significantly lower MCS than those in the SVS group before surgery (45.9 vs 50.8; P = .002; Mann-Whitney U test), but not after surgery. There was no difference between the two groups in terms of postoperative change in MCS. CONCLUSIONS: SVS is associated with a statistically significant and clinically meaningful improvement in generic HRQL that is similar to that observed after ELC. These novel data lend further support to the clinical benefit of SVS and will help health care purchasers make decisions regarding the prioritization of vascular and general surgical services.