Systematic review
Systematic review of compression following treatment for varicose veins J. El-Sheikha1 , D. Carradice1 , S. Nandhra1 , C. Leung1 , G. E. Smith1 , B. Campbell2 and I. C. Chetter1 1 Academic Vascular Surgery Unit, Hull Royal Infirmary and Hull York Medical School/University of Hull, Hull, and 2 Department of Vascular Surgery, Royal Devon and Exeter Hospital and University of Exeter Medical School, Exeter, UK Correspondence to: Mr J. El-Sheikha, Academic Vascular Unit, 1st Floor Tower Block, Hull Royal Infirmary, Hull HU3 2JZ, UK (e-mail: [email protected])
Background: Consensus regarding compression following treatment of varicose veins has yet to be
reached. This systematic review aims to establish the optimal compression regimen after venous treatment. Methods: A systematic review of MEDLINE, Embase and CENTRAL was performed to identify randomized clinical trials (RCTs) investigating different compression strategies following treatment for superficial venous insufficiency. Results: Seven RCTs comparing different durations and methods of compression fulfilled the inclusion criteria. The treatment modality was open surgery in three trials, foam sclerotherapy in two and endovenous laser ablation (EVLA) in two trials. The quality of the studies was variable, and significant sources of potential bias were present. Both the studies and compression regimens used were heterogeneous. Ten products were used in six general regimens for a duration of 0–42 days. One study suggested that 7 days rather than 2 days of stockings following EVLA was associated with superior quality of life and less pain at 1 week. Another study reported that, following surgery, application of a compression stocking after 3 days of bandaging was associated with a slightly longer recovery than no compression after 3 days. One study recorded compliance clearly, finding it to be only 40 per cent. The quality and heterogeneity of the studies precluded meta-analysis. Conclusion: There is currently little quality evidence upon which to base any recommendations concerning compression following treatment for varicose veins. Paper accepted 16 January 2015 Published online 2 April 2015 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9788
Introduction
Superficial venous insufficiency of the leg is estimated to occur in 40–50 per cent of all adults1 – 3 , and manifests most commonly as varicose veins. These are associated with reduced quality of life (QoL), deteriorating over time as a proportion of patients progress to develop tissue damage and venous ulceration2 – 5 . Treatment for varicose veins is in high demand in the UK health service, with 30 000 interventions performed in 2013 alone6 . Recent guidance published by the UK National Institute for Health and Care Excellence (NICE)7 recommends a hierarchy of treatment options for patients who need intervention: endothermal ablation, including endovenous laser (EVLA) or radiofrequency (RFA) ablation; ultrasound-guided foam sclerotherapy (UGFS); and conventional open surgical ligation, stripping and phlebectomy. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
It is common practice to employ a period of limb compression following treatment, with the intention of assisting in successful target vein occlusion and reducing pain, swelling and bruising. There is considerable variation in the type and duration of compression employed, with no consensus as to best practice. The aim of this study was to identify the evidence regarding the optimal type and duration of compression following treatment for varicose veins.
Methods
A systematic review of randomized clinical trials (RCTs) comparing different compression regimens was conducted in May 2014. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines8 were used for reporting the search results. The methodological quality of the studies was determined using BJS 2015; 102: 719–725
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both the Cochrane Collaboration bias tool9 and the Jadad scoring system10 . The literature search and assessment for inclusion were carried out independently by two reviewers, and any disagreements were resolved by arbitration with a third author.
Search strategy A systematic review was performed using the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase databases. The search strategy aimed to include any RCT that compared different types or durations of compression following treatment of varicose veins. The search method used for CENTRAL and MEDLINE/Embase is detailed in Appendix S1 (supporting information). Indexed citations were included from database commencement to April 2014 inclusive. In addition, references within identified or related publications were reviewed to highlight any further studies.
Inclusion criteria RCTs were eligible for inclusion if they involved a comparison of different compression following the same treatment for symptomatic varicose veins involving the great saphenous vein (GSV), short saphenous vein, anterior accessory saphenous vein, or any combination of these.
Outcomes Outcomes of interest included patient-reported pain, complication rates, recovery times to normal activities or work, compliance with compression, success of the primary procedure and QoL. Procedural success was defined as the absence of reflux within the treated vein on duplex ultrasonography.
Exclusion criteria Studies were excluded if they involved the treatment of animals, asymptomatic uncomplicated varicose veins or patients with coexisting arterial insufficiency, or were not reported in English.
Data extraction and synthesis A basic description of the population, treatments and regimens under study was extracted, along with the outcomes under study. The intention was to perform a meta-analysis, if suitable comparable data were identified. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
Results
Literature search Systematic review of the literature identified 183 potential studies, of which 161 were discounted as ineligible after title and abstract review. After full-text review of the remaining 22 papers, seven11 – 17 were eligible for inclusion (Fig. 1).
Included studies The analysis included seven RCTs11 – 17 , of which the primary treatment was open conventional surgery in three studies11 – 13 , UGFS in two studies14,15 and EVLA in two16,17 (Table 1).
Risk of bias The methodological quality of the trials was variable, ranging from poor to good with a median Jadad score of 4 (range 2–5) (Table S1, supporting information). This deficit was due to inadequate description of randomization techniques13 , little or no assessor blinding at follow-up assessments11,12 , and lack of descriptive information regarding study drop-out or withdrawals11,13 . All studies reported their aims and proposed outcomes. All but one study13 proposed a primary outcome measure. Four RCTs11,12,15,17 performed a prospective power calculation based on the primary outcome, and one16 undertook a post hoc analysis of the sample size. Of the four studies, that of Biswas and colleagues11 was the most credible; their estimation was based on a 1-point difference on a pain scale. The remaining three RCTs were based on fairly large differences in outcomes: 20 per cent difference in oedema12 and a 5-point difference15 in the Aberdeen Varicose Vein Questionnaire (AVVQ – a disease-specific QoL instrument18 ), and 33 per cent relative difference in pain on a 0–10-cm visual analogue scale (VAS)17 . Of these four studies, the recruitment fell slightly short of target in one15 and loss to follow-up was exceeded in two others12,17 . A post hoc analysis of required sample size was performed by Bakker and co-workers16 , who gave insufficient detail to examine their claim that the study was powered to detect clinically significant differences in domains of the generic QoL instrument Short Form 36 (SF-36®; QualityMetric, Lincoln, Rhode Island, USA)19,20 and pain, scored on a VAS. In fact, the sample size was insufficient to detect anything other than large differences in SF-36® physical domains20 . Of the remaining two studies, one14 acknowledged the sample size to be arbitrary and the other13 made no reference to a target sample size. www.bjs.co.uk
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Records identified through database searching (CENTRAL, MEDLINE and Embase) n = 182
Additional records identified through other sources n=1
Combined records n = 183
Records remaining after removal of duplicates n = 161 Records excluded following title/abstract review n = 139 Full-text articles assessed for eligibility n = 22 Full-text articles excluded n = 15 Not an RCT n = 6 No comparison of compression n = 5 Unrelated n = 4 Studies included n=7 Fig. 1
PRISMA flow chart of randomized clinical trials (RCTs) comparing different compression regimens identified
There were multiple other methodological issues. In the study of Biswas et al.11 , complications were entirely patient-reported, with no details on what training or information was given to patients in order to do this. Parametric hypothesis testing was also performed on non-normally distributed data. Houtermans-Auckel and colleagues12 recruited patients undergoing bilateral treatment, yet did not say how they accounted for the potential confounding this may cause. Rodrigus and Bleyn13 applied a 3-point arbitrary subjective ordinal score to all their outcomes, which was then transformed into a percentage through a mechanism that was never explained. O’Hare et al.15 also recruited patients with bilateral disease. Each leg was randomized separately, which means an individual patient may have a leg in both study groups. However, only a small number of patients with bilateral disease were actually recruited in this RCT. Significant numbers of patients were excluded from the analysis in several studies. Bakker and colleagues16 excluded 26 per cent of their randomized sample from analysis. The reasons included incomplete consent (13 per cent), did not receive treatment (8 per cent), incomplete outcomes (8 per cent) and did not comply with compression (4 per cent). Elderman and co-workers17 excluded 29 per cent of their study population for the following reasons: procedure unsuccessful (4 per cent), no show of © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
patient (5 per cent), withdrawal of informed consent (2 per cent), arterial problem (1 per cent), deep venous insufficiency (1 per cent), oedema (1 per cent), previous surgery (1 per cent) and missing data (15 per cent). This violated the intention-to-treat analysis and draws the results of the studies into question.
Compression regimens A total of 969 limbs were included across seven studies (Table 1). The majority of patients underwent conventional open surgery (573), with the remainder having EVLA (204) or UGFS (184). Overall, 440 limbs were randomized to seven shorter-duration groups and 529 to eight longer-duration groups in the respective trials. Rodrigus and Bleyn13 included two comparative long-duration groups. The duration of compression applied was highly variable (Table S2, supporting information). Short durations ranged from 0 days14 to 7 days11,13 , whereas long durations ranged from 5 days15 to 42 days13 . In one study15 , the total duration of compression was the same in both groups, but stronger compression was applied for differing intervals, immediately after intervention. In the open surgery trials, the shortest duration of compression tested was 3 days12 , and the longest was 42 days13 . The endovenous (endothermal and UGFS) trials investigated shorter intervals overall, with the range www.bjs.co.uk
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Table 1
J. El-Sheikha, D. Carradice, S. Nandhra, C. Leung, G. E. Smith, B. Campbell and I. C. Chetter
General characteristics of randomized clinical trials comparing different compression regimens
Reference Surgery Biswas et al.11 (2007)
CEAP clinical severity Concomitant treatment Duration of Duration of No. of Mean age Female of tributaries* follow-up (weeks) compression legs (years) sex (%) classification* Anaesthesia*
6
Houtermans-Auckel et al.12 (2009)
4
Rodrigus and Bleyn13 (1991)
8
UGFS Hamel-Desnos et al.14 (2010)
4
O’Hare et al.15 (2010)
EVLA Bakker et al.16 (2013) Elderman et al.17 (2014)
6
12 6
Short
110
48
66
Long
110
47
63
Short Long Short Long (1) Long (2)
52 52 84 84 89
49 50 n.r. n.r. n.r.
63 73 n.r. n.r. n.r.
Short† Long Short
29 31 61
53 61 60
97 87 51
Long
63
59
63
Short Long Short
48 45 56
50 51 51
n.r. n.r. 80
Long
55
55
82
C2 (96) C3–4 (4) C2 (93) C3–4 (7) C2–3 (100) C2–3 (100) n.r. n.r. n.r. n.r. n.r. C2 (43) C3–5 (57) C2 (49) C3–5 (50) n.r. n.r. C2 (53) C3–4 (48) C2 (62) C3–4 (39)
n.r.
Yes
n.r.
Yes
Spinal (90) Spinal (90) n.r. n.r. n.r.
Yes (48) Yes (52) Yes Yes Yes
n.r.
No
n.r.
Yes
TLA
No
TLA
No
*Values in parentheses are percentages. †No compression. CEAP, Clinical Etiologic Anatomic Pathophysiologic; n.r., not reported; UGFS, ultrasound-guided foam sclerotherapy; EVLA, endovenous laser ablation; TLA, tumescent local anaesthesia.
following UGFS from no compression at all to a duration of 21 days14 . The two EVLA studies compared compression of 2 versus 7 days16 and 1 versus 14 days17 . As with duration, there was considerable variation in the type of compression systems used; ten types of bandages and stockings were employed in different regimens (Fig. S1, supporting information).
Outcomes Pain and analgesia Patient-reported QoL impairment secondary to postprocedural pain was recorded using the SF-36® bodily pain domain in two RCTs. O’Hare and colleagues15 found no difference following UGFS at 6 weeks, but Bakker et al.16 observed a large difference at 1 week after EVLA: patients still in compression reported significantly higher QoL than those who were in compression for 2 days (mean(s.d.) score 86(18) versus 66(21) respectively; P < 0.001). At 6 weeks, however, there was no difference between short-duration (2 days) and long-duration (7 days) groups. Post-treatment pain scales were used in five studies. In keeping with their SF-36® pain findings, Bakker and co-workers16 reported less pain at 1 week in patients having © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
ongoing compression, compared with pain in those with only 2 days of compression (mean(s.d.) score 3.7(2.1) versus 2.0(2.0) respectively; P < 0.001). There was no difference between the groups whilst both groups were still in compression (2 days) and when both were without compression (6 weeks). Elderman et al.17 also reported that pain scores were lower in compression over the first week than without compression after 24 h; although detailed figures were not provided, a comparison of effect sizes appeared to show that no compression was associated with more pain at all time points. Biswas and colleagues11 found that reported pain was slightly lower in the long compression group at 1 week, even though both groups had received exactly the same treatment until then. There was no difference at 4 or 6 weeks after surgery. The difference at 1 week is hard to explain and it is unclear whether this was a true difference, or due to bias or a methodological flaw. Houterman-Auckel et al.12 did not detect any significant difference in pain on day 3 (both groups in compression), day 14 (compression removed in the short-term group) or day 28 (the final day of compression in the long-term group) after surgery. O’Hare and co-workers15 also reported no difference at 2 or 6 weeks following UGFS. www.bjs.co.uk
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Rodrigus and Bleyn13 reported similar pain in each of their groups at 2 months, but their scoring system was unclear. Three RCTs looked at analgesia requirement. Biswas and colleagues11 found that the group with longer compression used less analgesia (data not given). Elderman et al.17 showed that short compression was associated with increased analgesic requirements (paracetamol), but conversely no difference was noted in the use of non-steroidal anti-inflammatory drugs or opiates. Hamel-Desnos and co-workers14 found that only five patients had taken any analgesia by day 28, with no intergroup difference.
differences in complication rates for different duration of compression. Complications reported included sensory disturbance11,12,17 , bruising11,14 , bleeding12 , haempigmentation13 – 15 , thrombophlebitis14 – 17 , atoma13,16 , 11,12,17 infection , induration13,14 , seroma12 , matting (post14 UGFS) , visual disturbance (post-UGFS)14 , retained blood (following UGFS, requiring aspiration)15 , allergy ulceration at injection site (following UGFS) and deep vein thrombosis (DVT)14,16 . Despite their questionnaire stating specifically that patients should not report bruising, Biswas et al.11 concluded that there was no difference in this outcome.
Quality of life Four RCTs recorded patient-reported QoL. The disease-specific AVVQ was used by O’Hare et al.15 following UGFS, and by Elderman and colleagues17 following EVLA. The Chronic Venous Insufficiency Questionnaire (CIVIQ)21 was used by Hamel-Desnos and co-workers14 following UGFS. No RCT demonstrated any difference between study groups from these disease-specific QoL questionnaires. Along with Bakker and colleagues16 , O’Hare et al.15 and Elderman et al.17 also assessed generic QoL using SF-36®. In the presence of an adequate sample size, SF-36® should detect differences between the groups associated with any morbidity or dysfunction related to the intervention (compression regimen). The results of Bakker et al.16 for the domain of bodily pain favouring longer compression were discussed above. In keeping with this, they also found large differences at 1 week in the domains of physical function (mean(s.d.) score 85.1(11.2) versus 95.7(10.1); P < 0.001) and vitality (75.0(13.0) versus 83.7(13.4); P = 0.030), with those in compression for only 2 days reporting worse QoL. As with pain, these differences had resolved by 6 weeks. O’Hare and colleagues15 and Elderman and co-workers17 also reported no difference in any domain at 6 weeks after UGFS and EVLA respectively.
Compliance Compliance with stockings was mentioned in two RCTs. Hamel-Desnos and colleagues14 found that only 40 per cent of patients were fully compliant with compression every day, with the mean number of days of compliance only half that intended. They found that the poor compliance was due to discomfort (32 per cent), painful tightness (11 per cent), itching (9 per cent), irritation (6 per cent), swelling (4 per cent), cold feet (4 per cent) and other (37 per cent). Bakker and co-workers16 excluded 4 per cent of their randomized patients as they did not comply with compression; it is unclear whether this accounted for all their patients who failed to comply with advice on compression.
Duration of recovery Two studies measured recovery time. Houterman-Auckel et al.12 found that their short-duration group (3 days) returned to work earlier after surgery than those in compression for 28 days (mean(s.d.) 11(7.5) versus 15(8.4) days respectively; P = 0.020). The long-duration group returned to work wearing their stocking. Elderman and co-workers17 did not detect any difference in time to return to work following EVLA in those who had 24 h or 14 days of compression. Postoperative complications Complications following treatment were reported in all the trials studied. None of the studies reported any © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
Treatment success Only three endovenous RCTs assessed technical efficacy by means of ultrasound imaging; no significant differences in target vein occlusion were observed following UGFS14,15 or EVLA16 . Using a subjective scoring system, Rodrigus and Bleyn13 did not detect any difference in residual varicosities at 2 months after open surgery. Meta-analysis Owing to the high levels of heterogeneity in the RCTs in terms of the regimens under study, the outcomes measured, and the quality and timing of outcome assessment, meta-analysis was deemed inappropriate. Discussion
Compression therapy has an established role in the conservative management of venous disease. It combats venous hypertension, promoting antegrade flow of blood from the leg, improving calf muscle function and decreasing venous reflux22,23 . However, in the majority of patients with non-ulcerated varicose veins it is not the optimal treatment, as there is level 1 evidence that conventional surgery offers greater improvement in QoL24 . In venous ulcer disease www.bjs.co.uk
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compression has a clear role, both increasing healing rates and reducing recurrence25,26 . The fundamental problem with compression is that its benefit is conferred only when the compression is in place; yet compliance is poor27,28 . Up to 63 per cent of patients are non-compliant within 1 year, and non-compliance is high even in the presence of ulceration28 . Poor compliance may be due to socioeconomic factors29 , poor education30 , discomfort31 and cosmetic concern. In an elderly population, the patient’s ability to apply the compression stockings is a factor. One study32 demonstrated that 15 per cent were physically unable to apply their compression stockings and 26 per cent needed considerable help. The role of compression following interventional treatment is unclear. It is thought to reduce pain, complications such as swelling, bleeding, bruising, haematoma and DVT. Following some treatments, such as UGFS, it may even increase the efficacy of the procedure. It has been suggested that compression may be one of the factors responsible for the observed variation in efficacy of UGFS. This systematic review shows that there is limited evidence upon which to base any guidance on compression regimens following treatment for varicose veins. Even when confining this review to RCTs, there are concerns with the overall methodological quality of the included studies; the most significant flaw is inadequate sample size. Heterogeneity of the regimens compared, and of the outcomes and their timing, preclude any meaningful meta-analysis. The only really significant finding was from an RCT comparing 2 versus 7 days of compression after EVLA (with no concomitant treatment of tributaries), which reported beneficial effects for 7 days of compression16 . In contrast, a single study12 found that stopping compression after just 3 days following surgery was associated with a more rapid return to work. Neither of these results appeared sufficiently strong to form the basis of any recommendation about practice. A key confounder in all studies of compression treatment for venous disease is the issue of compliance; most RCTs did not report this outcome. The only study that examined it found very high levels of non-compliance. Although non-compliance does not strictly impact upon a study analysed by intention to treat, it is important to establish whether there are any benefits to compression where it is used successfully. A study33 of the management of varicose veins among UK vascular surgeons in 2006 reported that elasticated bandages remained the most prevalent form of compression after treatment, with 77 per cent of respondents changing these for compression stockings subsequently, © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
but with highly diverse regimens and duration. There is currently insufficient information to make any recommendations about compression therapy after interventions for varicose veins. Disclosure
The authors declare no conflict of interest. References 1 Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg 2004; 40: 650–659. 2 Evans CJ, Allan PL, Lee AJ, Bradbury AW, Ruckley CV, Fowkes FG. Prevalence of venous reflux in the general population on duplex scanning: the Edinburgh vein study. J Vasc Surg 1998; 28: 767–776. 3 Maurins U, Hoffmann BH, Losch C, Jockel KH, Rabe E, Pannier F. Distribution and prevalence of reflux in the superficial and deep venous system in the general population – results from the Bonn Vein Study, Germany. J Vasc Surg 2008; 48: 680–687. 4 Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol 2005; 15: 175–184. 5 Darvall KA, Bate GR, Adam DJ, Bradbury AW. Generic health-related quality of life is significantly worse in varicose vein patients with lower limb symptoms independent of CEAP clinical grade. Eur J Vasc Endovasc Surg 2012; 44: 341–344. 6 Health and Social Care Information Centre. Hospital Episode Statistics. http://www.hscic.gov.uk/hes [accessed 1 May 2014]. 7 Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ 2013; 347: f4279. 8 Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700. 9 Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD et al.; Cochrane Statistical Methods Group. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928. 10 Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials 1996; 17: 1–12. 11 Biswas S, Clark A, Shields DA. Randomised clinical trial of the duration of compression therapy after varicose vein surgery. Eur J Vasc Endovasc Surg 2007; 33: 631–637.
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12 Houtermans-Auckel JP, van Rossum E, Teijink JA, Dahlmans AA, Eussen EF, Nicolai SP et al. To wear or not to wear compression stockings after varicose vein stripping: a randomised controlled trial. Eur J Vasc Endovasc Surg 2009; 38: 387–391. 13 Rodrigus I, Bleyn J. For how long do we have to advise elastic support after varicose vein surgery? A prospective randomized study. Phlebology 1991; 6: 95–98. 14 Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg 2010; 39: 500–507. 15 O’Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg 2010; 97: 650–656. 16 Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg 2013; 46: 588–592. 17 Elderman JH, Krasznai AG, Voogd AC, Hulsewé KWE, Sikkink CJJM. Role of compression stockings after endovenous laser therapy for primary varicosis. J Vasc Surg Venous Lymphat Disord 2014; 2: 289–296. 18 Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK, Krukowski ZH. Towards measurement of outcome for patients with varicose veins. Qual Health Care 1993; 2: 5–10. 19 Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care 1988; 26: 724–735. 20 Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473–483. 21 Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res 1996; 5: 539–554. 22 Zajkowski PJ, Proctor MC, Wakefield TW, Bloom J, Blessing B, Greenfield LJ. Compression stockings and venous function. Arch Surg 2002; 137: 1064–1068.
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23 Ibegbuna V, Delis KT, Nicolaides AN, Aina O. Effect of elastic compression stockings on venous hemodynamics during walking. J Vasc Surg 2003; 37: 420–425. 24 Michaels JA, Campbell WB, Brazier JE, Macintyre JB, Palfreyman SJ, Ratcliffe J et al. Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial). Health Technol Assess 2006; 10: 1–196, iii–iv. 25 O’Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev 2012; (11)CD000265. 26 Partsch H, Flour M, Smith PC; International Compression Club. Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP. Int Angiol 2008; 27: 193–219. 27 Labropoulos N, Leon M, Volteas N, Nicolaides AN. Acute and long-term effect of elastic stockings in patients with varicose veins. Int Angiol 1994; 13: 119–123. 28 Mayberry JC, Moneta GL, Taylor LM Jr, Porter JM. Fifteen-year results of ambulatory compression therapy for chronic venous ulcers. Surgery 1991; 109: 575–581. 29 Kiev J, Noyes LD, Rice JC, Kerstein MD. Patient compliance with fitted compression hosiery monitored by photoplethysmography. Arch Phys Med Rehabil 1990; 71: 376–379. 30 Dale JJ, Gibson B. Information will enhance compliance. Informing clients about compression hosiery. Prof Nurse 1992; 7: 755–756, 758–760. 31 Nelson EA, Bell-Syer SE. Compression for preventing recurrence of venous ulcers. Cochrane Database Syst Rev 2012; (8)CD002303. 32 Franks PJ, Moffatt CJ, Connolly M, Bosanquet N, Oldroyd MI, Greenhalgh RM et al. Factors associated with healing leg ulceration with high compression. Age Ageing 1995; 24: 407–410. 33 Edwards AG, Baynham S, Lees T, Mitchell DC. Management of varicose veins: a survey of current practice by members of the Vascular Society of Great Britain and Ireland. Ann R Coll Surg Engl 2009; 91: 77–80.
Supporting information
Additional supporting information may be found in the online version of this article: Appendix S1 Search strategy (Word document) Fig. S1 Frequency of general compression regimens used in the short- and long-duration compression arms of randomized clinical trials (Word document) Table S1 Assessment of bias in randomized clinical trials comparing different compression regimens (Word document) Table S2 Summary of randomized clinical trials comparing different compression regimens (Word document)
© 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
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BJS 2015; 102: 719–725
Systematic review of compression following treatment for varicose veins J. El-Sheikha1 , D. Carradice1 , S. Nandhra1 , C. Leung1 , G. E. Smith1 , B. Campbell2 and I. C. Chetter1 1 Academic Vascular Surgery Unit, Hull Royal Infirmary and Hull York Medical School/University of Hull, Hull, and 2 Department of Vascular Surgery, Royal Devon and Exeter Hospital and University of Exeter Medical School, Exeter, UK Correspondence to: Mr J. El-Sheikha, Academic Vascular Unit, 1st Floor Tower Block, Hull Royal Infirmary, Hull HU3 2JZ, UK (e-mail: [email protected])
Background: Consensus regarding compression following treatment of varicose veins has yet to be
reached. This systematic review aims to establish the optimal compression regimen after venous treatment. Methods: A systematic review of MEDLINE, Embase and CENTRAL was performed to identify randomized clinical trials (RCTs) investigating different compression strategies following treatment for superficial venous insufficiency. Results: Seven RCTs comparing different durations and methods of compression fulfilled the inclusion criteria. The treatment modality was open surgery in three trials, foam sclerotherapy in two and endovenous laser ablation (EVLA) in two trials. The quality of the studies was variable, and significant sources of potential bias were present. Both the studies and compression regimens used were heterogeneous. Ten products were used in six general regimens for a duration of 0–42 days. One study suggested that 7 days rather than 2 days of stockings following EVLA was associated with superior quality of life and less pain at 1 week. Another study reported that, following surgery, application of a compression stocking after 3 days of bandaging was associated with a slightly longer recovery than no compression after 3 days. One study recorded compliance clearly, finding it to be only 40 per cent. The quality and heterogeneity of the studies precluded meta-analysis. Conclusion: There is currently little quality evidence upon which to base any recommendations concerning compression following treatment for varicose veins. Paper accepted 16 January 2015 Published online 2 April 2015 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.9788
Introduction
Superficial venous insufficiency of the leg is estimated to occur in 40–50 per cent of all adults1 – 3 , and manifests most commonly as varicose veins. These are associated with reduced quality of life (QoL), deteriorating over time as a proportion of patients progress to develop tissue damage and venous ulceration2 – 5 . Treatment for varicose veins is in high demand in the UK health service, with 30 000 interventions performed in 2013 alone6 . Recent guidance published by the UK National Institute for Health and Care Excellence (NICE)7 recommends a hierarchy of treatment options for patients who need intervention: endothermal ablation, including endovenous laser (EVLA) or radiofrequency (RFA) ablation; ultrasound-guided foam sclerotherapy (UGFS); and conventional open surgical ligation, stripping and phlebectomy. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
It is common practice to employ a period of limb compression following treatment, with the intention of assisting in successful target vein occlusion and reducing pain, swelling and bruising. There is considerable variation in the type and duration of compression employed, with no consensus as to best practice. The aim of this study was to identify the evidence regarding the optimal type and duration of compression following treatment for varicose veins.
Methods
A systematic review of randomized clinical trials (RCTs) comparing different compression regimens was conducted in May 2014. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines8 were used for reporting the search results. The methodological quality of the studies was determined using BJS 2015; 102: 719–725
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both the Cochrane Collaboration bias tool9 and the Jadad scoring system10 . The literature search and assessment for inclusion were carried out independently by two reviewers, and any disagreements were resolved by arbitration with a third author.
Search strategy A systematic review was performed using the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and Embase databases. The search strategy aimed to include any RCT that compared different types or durations of compression following treatment of varicose veins. The search method used for CENTRAL and MEDLINE/Embase is detailed in Appendix S1 (supporting information). Indexed citations were included from database commencement to April 2014 inclusive. In addition, references within identified or related publications were reviewed to highlight any further studies.
Inclusion criteria RCTs were eligible for inclusion if they involved a comparison of different compression following the same treatment for symptomatic varicose veins involving the great saphenous vein (GSV), short saphenous vein, anterior accessory saphenous vein, or any combination of these.
Outcomes Outcomes of interest included patient-reported pain, complication rates, recovery times to normal activities or work, compliance with compression, success of the primary procedure and QoL. Procedural success was defined as the absence of reflux within the treated vein on duplex ultrasonography.
Exclusion criteria Studies were excluded if they involved the treatment of animals, asymptomatic uncomplicated varicose veins or patients with coexisting arterial insufficiency, or were not reported in English.
Data extraction and synthesis A basic description of the population, treatments and regimens under study was extracted, along with the outcomes under study. The intention was to perform a meta-analysis, if suitable comparable data were identified. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
Results
Literature search Systematic review of the literature identified 183 potential studies, of which 161 were discounted as ineligible after title and abstract review. After full-text review of the remaining 22 papers, seven11 – 17 were eligible for inclusion (Fig. 1).
Included studies The analysis included seven RCTs11 – 17 , of which the primary treatment was open conventional surgery in three studies11 – 13 , UGFS in two studies14,15 and EVLA in two16,17 (Table 1).
Risk of bias The methodological quality of the trials was variable, ranging from poor to good with a median Jadad score of 4 (range 2–5) (Table S1, supporting information). This deficit was due to inadequate description of randomization techniques13 , little or no assessor blinding at follow-up assessments11,12 , and lack of descriptive information regarding study drop-out or withdrawals11,13 . All studies reported their aims and proposed outcomes. All but one study13 proposed a primary outcome measure. Four RCTs11,12,15,17 performed a prospective power calculation based on the primary outcome, and one16 undertook a post hoc analysis of the sample size. Of the four studies, that of Biswas and colleagues11 was the most credible; their estimation was based on a 1-point difference on a pain scale. The remaining three RCTs were based on fairly large differences in outcomes: 20 per cent difference in oedema12 and a 5-point difference15 in the Aberdeen Varicose Vein Questionnaire (AVVQ – a disease-specific QoL instrument18 ), and 33 per cent relative difference in pain on a 0–10-cm visual analogue scale (VAS)17 . Of these four studies, the recruitment fell slightly short of target in one15 and loss to follow-up was exceeded in two others12,17 . A post hoc analysis of required sample size was performed by Bakker and co-workers16 , who gave insufficient detail to examine their claim that the study was powered to detect clinically significant differences in domains of the generic QoL instrument Short Form 36 (SF-36®; QualityMetric, Lincoln, Rhode Island, USA)19,20 and pain, scored on a VAS. In fact, the sample size was insufficient to detect anything other than large differences in SF-36® physical domains20 . Of the remaining two studies, one14 acknowledged the sample size to be arbitrary and the other13 made no reference to a target sample size. www.bjs.co.uk
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Records identified through database searching (CENTRAL, MEDLINE and Embase) n = 182
Additional records identified through other sources n=1
Combined records n = 183
Records remaining after removal of duplicates n = 161 Records excluded following title/abstract review n = 139 Full-text articles assessed for eligibility n = 22 Full-text articles excluded n = 15 Not an RCT n = 6 No comparison of compression n = 5 Unrelated n = 4 Studies included n=7 Fig. 1
PRISMA flow chart of randomized clinical trials (RCTs) comparing different compression regimens identified
There were multiple other methodological issues. In the study of Biswas et al.11 , complications were entirely patient-reported, with no details on what training or information was given to patients in order to do this. Parametric hypothesis testing was also performed on non-normally distributed data. Houtermans-Auckel and colleagues12 recruited patients undergoing bilateral treatment, yet did not say how they accounted for the potential confounding this may cause. Rodrigus and Bleyn13 applied a 3-point arbitrary subjective ordinal score to all their outcomes, which was then transformed into a percentage through a mechanism that was never explained. O’Hare et al.15 also recruited patients with bilateral disease. Each leg was randomized separately, which means an individual patient may have a leg in both study groups. However, only a small number of patients with bilateral disease were actually recruited in this RCT. Significant numbers of patients were excluded from the analysis in several studies. Bakker and colleagues16 excluded 26 per cent of their randomized sample from analysis. The reasons included incomplete consent (13 per cent), did not receive treatment (8 per cent), incomplete outcomes (8 per cent) and did not comply with compression (4 per cent). Elderman and co-workers17 excluded 29 per cent of their study population for the following reasons: procedure unsuccessful (4 per cent), no show of © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
patient (5 per cent), withdrawal of informed consent (2 per cent), arterial problem (1 per cent), deep venous insufficiency (1 per cent), oedema (1 per cent), previous surgery (1 per cent) and missing data (15 per cent). This violated the intention-to-treat analysis and draws the results of the studies into question.
Compression regimens A total of 969 limbs were included across seven studies (Table 1). The majority of patients underwent conventional open surgery (573), with the remainder having EVLA (204) or UGFS (184). Overall, 440 limbs were randomized to seven shorter-duration groups and 529 to eight longer-duration groups in the respective trials. Rodrigus and Bleyn13 included two comparative long-duration groups. The duration of compression applied was highly variable (Table S2, supporting information). Short durations ranged from 0 days14 to 7 days11,13 , whereas long durations ranged from 5 days15 to 42 days13 . In one study15 , the total duration of compression was the same in both groups, but stronger compression was applied for differing intervals, immediately after intervention. In the open surgery trials, the shortest duration of compression tested was 3 days12 , and the longest was 42 days13 . The endovenous (endothermal and UGFS) trials investigated shorter intervals overall, with the range www.bjs.co.uk
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Table 1
J. El-Sheikha, D. Carradice, S. Nandhra, C. Leung, G. E. Smith, B. Campbell and I. C. Chetter
General characteristics of randomized clinical trials comparing different compression regimens
Reference Surgery Biswas et al.11 (2007)
CEAP clinical severity Concomitant treatment Duration of Duration of No. of Mean age Female of tributaries* follow-up (weeks) compression legs (years) sex (%) classification* Anaesthesia*
6
Houtermans-Auckel et al.12 (2009)
4
Rodrigus and Bleyn13 (1991)
8
UGFS Hamel-Desnos et al.14 (2010)
4
O’Hare et al.15 (2010)
EVLA Bakker et al.16 (2013) Elderman et al.17 (2014)
6
12 6
Short
110
48
66
Long
110
47
63
Short Long Short Long (1) Long (2)
52 52 84 84 89
49 50 n.r. n.r. n.r.
63 73 n.r. n.r. n.r.
Short† Long Short
29 31 61
53 61 60
97 87 51
Long
63
59
63
Short Long Short
48 45 56
50 51 51
n.r. n.r. 80
Long
55
55
82
C2 (96) C3–4 (4) C2 (93) C3–4 (7) C2–3 (100) C2–3 (100) n.r. n.r. n.r. n.r. n.r. C2 (43) C3–5 (57) C2 (49) C3–5 (50) n.r. n.r. C2 (53) C3–4 (48) C2 (62) C3–4 (39)
n.r.
Yes
n.r.
Yes
Spinal (90) Spinal (90) n.r. n.r. n.r.
Yes (48) Yes (52) Yes Yes Yes
n.r.
No
n.r.
Yes
TLA
No
TLA
No
*Values in parentheses are percentages. †No compression. CEAP, Clinical Etiologic Anatomic Pathophysiologic; n.r., not reported; UGFS, ultrasound-guided foam sclerotherapy; EVLA, endovenous laser ablation; TLA, tumescent local anaesthesia.
following UGFS from no compression at all to a duration of 21 days14 . The two EVLA studies compared compression of 2 versus 7 days16 and 1 versus 14 days17 . As with duration, there was considerable variation in the type of compression systems used; ten types of bandages and stockings were employed in different regimens (Fig. S1, supporting information).
Outcomes Pain and analgesia Patient-reported QoL impairment secondary to postprocedural pain was recorded using the SF-36® bodily pain domain in two RCTs. O’Hare and colleagues15 found no difference following UGFS at 6 weeks, but Bakker et al.16 observed a large difference at 1 week after EVLA: patients still in compression reported significantly higher QoL than those who were in compression for 2 days (mean(s.d.) score 86(18) versus 66(21) respectively; P < 0.001). At 6 weeks, however, there was no difference between short-duration (2 days) and long-duration (7 days) groups. Post-treatment pain scales were used in five studies. In keeping with their SF-36® pain findings, Bakker and co-workers16 reported less pain at 1 week in patients having © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
ongoing compression, compared with pain in those with only 2 days of compression (mean(s.d.) score 3.7(2.1) versus 2.0(2.0) respectively; P < 0.001). There was no difference between the groups whilst both groups were still in compression (2 days) and when both were without compression (6 weeks). Elderman et al.17 also reported that pain scores were lower in compression over the first week than without compression after 24 h; although detailed figures were not provided, a comparison of effect sizes appeared to show that no compression was associated with more pain at all time points. Biswas and colleagues11 found that reported pain was slightly lower in the long compression group at 1 week, even though both groups had received exactly the same treatment until then. There was no difference at 4 or 6 weeks after surgery. The difference at 1 week is hard to explain and it is unclear whether this was a true difference, or due to bias or a methodological flaw. Houterman-Auckel et al.12 did not detect any significant difference in pain on day 3 (both groups in compression), day 14 (compression removed in the short-term group) or day 28 (the final day of compression in the long-term group) after surgery. O’Hare and co-workers15 also reported no difference at 2 or 6 weeks following UGFS. www.bjs.co.uk
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Rodrigus and Bleyn13 reported similar pain in each of their groups at 2 months, but their scoring system was unclear. Three RCTs looked at analgesia requirement. Biswas and colleagues11 found that the group with longer compression used less analgesia (data not given). Elderman et al.17 showed that short compression was associated with increased analgesic requirements (paracetamol), but conversely no difference was noted in the use of non-steroidal anti-inflammatory drugs or opiates. Hamel-Desnos and co-workers14 found that only five patients had taken any analgesia by day 28, with no intergroup difference.
differences in complication rates for different duration of compression. Complications reported included sensory disturbance11,12,17 , bruising11,14 , bleeding12 , haempigmentation13 – 15 , thrombophlebitis14 – 17 , atoma13,16 , 11,12,17 infection , induration13,14 , seroma12 , matting (post14 UGFS) , visual disturbance (post-UGFS)14 , retained blood (following UGFS, requiring aspiration)15 , allergy ulceration at injection site (following UGFS) and deep vein thrombosis (DVT)14,16 . Despite their questionnaire stating specifically that patients should not report bruising, Biswas et al.11 concluded that there was no difference in this outcome.
Quality of life Four RCTs recorded patient-reported QoL. The disease-specific AVVQ was used by O’Hare et al.15 following UGFS, and by Elderman and colleagues17 following EVLA. The Chronic Venous Insufficiency Questionnaire (CIVIQ)21 was used by Hamel-Desnos and co-workers14 following UGFS. No RCT demonstrated any difference between study groups from these disease-specific QoL questionnaires. Along with Bakker and colleagues16 , O’Hare et al.15 and Elderman et al.17 also assessed generic QoL using SF-36®. In the presence of an adequate sample size, SF-36® should detect differences between the groups associated with any morbidity or dysfunction related to the intervention (compression regimen). The results of Bakker et al.16 for the domain of bodily pain favouring longer compression were discussed above. In keeping with this, they also found large differences at 1 week in the domains of physical function (mean(s.d.) score 85.1(11.2) versus 95.7(10.1); P < 0.001) and vitality (75.0(13.0) versus 83.7(13.4); P = 0.030), with those in compression for only 2 days reporting worse QoL. As with pain, these differences had resolved by 6 weeks. O’Hare and colleagues15 and Elderman and co-workers17 also reported no difference in any domain at 6 weeks after UGFS and EVLA respectively.
Compliance Compliance with stockings was mentioned in two RCTs. Hamel-Desnos and colleagues14 found that only 40 per cent of patients were fully compliant with compression every day, with the mean number of days of compliance only half that intended. They found that the poor compliance was due to discomfort (32 per cent), painful tightness (11 per cent), itching (9 per cent), irritation (6 per cent), swelling (4 per cent), cold feet (4 per cent) and other (37 per cent). Bakker and co-workers16 excluded 4 per cent of their randomized patients as they did not comply with compression; it is unclear whether this accounted for all their patients who failed to comply with advice on compression.
Duration of recovery Two studies measured recovery time. Houterman-Auckel et al.12 found that their short-duration group (3 days) returned to work earlier after surgery than those in compression for 28 days (mean(s.d.) 11(7.5) versus 15(8.4) days respectively; P = 0.020). The long-duration group returned to work wearing their stocking. Elderman and co-workers17 did not detect any difference in time to return to work following EVLA in those who had 24 h or 14 days of compression. Postoperative complications Complications following treatment were reported in all the trials studied. None of the studies reported any © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
Treatment success Only three endovenous RCTs assessed technical efficacy by means of ultrasound imaging; no significant differences in target vein occlusion were observed following UGFS14,15 or EVLA16 . Using a subjective scoring system, Rodrigus and Bleyn13 did not detect any difference in residual varicosities at 2 months after open surgery. Meta-analysis Owing to the high levels of heterogeneity in the RCTs in terms of the regimens under study, the outcomes measured, and the quality and timing of outcome assessment, meta-analysis was deemed inappropriate. Discussion
Compression therapy has an established role in the conservative management of venous disease. It combats venous hypertension, promoting antegrade flow of blood from the leg, improving calf muscle function and decreasing venous reflux22,23 . However, in the majority of patients with non-ulcerated varicose veins it is not the optimal treatment, as there is level 1 evidence that conventional surgery offers greater improvement in QoL24 . In venous ulcer disease www.bjs.co.uk
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compression has a clear role, both increasing healing rates and reducing recurrence25,26 . The fundamental problem with compression is that its benefit is conferred only when the compression is in place; yet compliance is poor27,28 . Up to 63 per cent of patients are non-compliant within 1 year, and non-compliance is high even in the presence of ulceration28 . Poor compliance may be due to socioeconomic factors29 , poor education30 , discomfort31 and cosmetic concern. In an elderly population, the patient’s ability to apply the compression stockings is a factor. One study32 demonstrated that 15 per cent were physically unable to apply their compression stockings and 26 per cent needed considerable help. The role of compression following interventional treatment is unclear. It is thought to reduce pain, complications such as swelling, bleeding, bruising, haematoma and DVT. Following some treatments, such as UGFS, it may even increase the efficacy of the procedure. It has been suggested that compression may be one of the factors responsible for the observed variation in efficacy of UGFS. This systematic review shows that there is limited evidence upon which to base any guidance on compression regimens following treatment for varicose veins. Even when confining this review to RCTs, there are concerns with the overall methodological quality of the included studies; the most significant flaw is inadequate sample size. Heterogeneity of the regimens compared, and of the outcomes and their timing, preclude any meaningful meta-analysis. The only really significant finding was from an RCT comparing 2 versus 7 days of compression after EVLA (with no concomitant treatment of tributaries), which reported beneficial effects for 7 days of compression16 . In contrast, a single study12 found that stopping compression after just 3 days following surgery was associated with a more rapid return to work. Neither of these results appeared sufficiently strong to form the basis of any recommendation about practice. A key confounder in all studies of compression treatment for venous disease is the issue of compliance; most RCTs did not report this outcome. The only study that examined it found very high levels of non-compliance. Although non-compliance does not strictly impact upon a study analysed by intention to treat, it is important to establish whether there are any benefits to compression where it is used successfully. A study33 of the management of varicose veins among UK vascular surgeons in 2006 reported that elasticated bandages remained the most prevalent form of compression after treatment, with 77 per cent of respondents changing these for compression stockings subsequently, © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd
but with highly diverse regimens and duration. There is currently insufficient information to make any recommendations about compression therapy after interventions for varicose veins. Disclosure
The authors declare no conflict of interest. References 1 Carpentier PH, Maricq HR, Biro C, Poncot-Makinen CO, Franco A. Prevalence, risk factors, and clinical patterns of chronic venous disorders of lower limbs: a population-based study in France. J Vasc Surg 2004; 40: 650–659. 2 Evans CJ, Allan PL, Lee AJ, Bradbury AW, Ruckley CV, Fowkes FG. Prevalence of venous reflux in the general population on duplex scanning: the Edinburgh vein study. J Vasc Surg 1998; 28: 767–776. 3 Maurins U, Hoffmann BH, Losch C, Jockel KH, Rabe E, Pannier F. Distribution and prevalence of reflux in the superficial and deep venous system in the general population – results from the Bonn Vein Study, Germany. J Vasc Surg 2008; 48: 680–687. 4 Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol 2005; 15: 175–184. 5 Darvall KA, Bate GR, Adam DJ, Bradbury AW. Generic health-related quality of life is significantly worse in varicose vein patients with lower limb symptoms independent of CEAP clinical grade. Eur J Vasc Endovasc Surg 2012; 44: 341–344. 6 Health and Social Care Information Centre. Hospital Episode Statistics. http://www.hscic.gov.uk/hes [accessed 1 May 2014]. 7 Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ 2013; 347: f4279. 8 Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009; 339: b2700. 9 Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD et al.; Cochrane Statistical Methods Group. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011; 343: d5928. 10 Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clin Trials 1996; 17: 1–12. 11 Biswas S, Clark A, Shields DA. Randomised clinical trial of the duration of compression therapy after varicose vein surgery. Eur J Vasc Endovasc Surg 2007; 33: 631–637.
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12 Houtermans-Auckel JP, van Rossum E, Teijink JA, Dahlmans AA, Eussen EF, Nicolai SP et al. To wear or not to wear compression stockings after varicose vein stripping: a randomised controlled trial. Eur J Vasc Endovasc Surg 2009; 38: 387–391. 13 Rodrigus I, Bleyn J. For how long do we have to advise elastic support after varicose vein surgery? A prospective randomized study. Phlebology 1991; 6: 95–98. 14 Hamel-Desnos CM, Guias BJ, Desnos PR, Mesgard A. Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression. Eur J Vasc Endovasc Surg 2010; 39: 500–507. 15 O’Hare JL, Stephens J, Parkin D, Earnshaw JJ. Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins. Br J Surg 2010; 97: 650–656. 16 Bakker NA, Schieven LW, Bruins RM, van den Berg M, Hissink RJ. Compression stockings after endovenous laser ablation of the great saphenous vein: a prospective randomized controlled trial. Eur J Vasc Endovasc Surg 2013; 46: 588–592. 17 Elderman JH, Krasznai AG, Voogd AC, Hulsewé KWE, Sikkink CJJM. Role of compression stockings after endovenous laser therapy for primary varicosis. J Vasc Surg Venous Lymphat Disord 2014; 2: 289–296. 18 Garratt AM, Macdonald LM, Ruta DA, Russell IT, Buckingham JK, Krukowski ZH. Towards measurement of outcome for patients with varicose veins. Qual Health Care 1993; 2: 5–10. 19 Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care 1988; 26: 724–735. 20 Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473–483. 21 Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res 1996; 5: 539–554. 22 Zajkowski PJ, Proctor MC, Wakefield TW, Bloom J, Blessing B, Greenfield LJ. Compression stockings and venous function. Arch Surg 2002; 137: 1064–1068.
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Supporting information
Additional supporting information may be found in the online version of this article: Appendix S1 Search strategy (Word document) Fig. S1 Frequency of general compression regimens used in the short- and long-duration compression arms of randomized clinical trials (Word document) Table S1 Assessment of bias in randomized clinical trials comparing different compression regimens (Word document) Table S2 Summary of randomized clinical trials comparing different compression regimens (Word document)
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