The Discord Outcome Analysis (DOA) as a Reporting Standard at Three Months and Five Years in Randomised Varicose Vein Treatment Trials

European Journal of Vascular and Endovascular Surgery

Volumn 57, Issue 2, 2019, Pages 267-274

  Kalodiki, Evi ^a,b,c   Azzam, Mustapha ^a   Schnatterbeck, Peter ^a,c   Geroulakos, George ^a,b   Lattimer, Christopher R ^a,b,c  

^a EALING HOSPITAL   (United Kingdom)

^b IMPERIAL COLLEGE LONDON   (United Kingdom)

^c NORTHWICK PARK HOSPITAL   (United Kingdom)

Author keywords

Discord outcome analysis; Endovenous laser ablation; Five year follow up; RCT; Ultrasound guided foam sclerotherapy; Varicose veins

Indexed keywords

SCLEROSING AGENT;

ARTICLE; CLINICAL ARTICLE; CLINICAL OUTCOME; DETERIORATION; DISCORD OUTCOME ANALYSIS; DISEASE SEVERITY; FEMALE; FOLLOW UP; HUMAN; INTERMETHOD COMPARISON; LASER SURGERY; MALE; PHLEBECTOMY; PLETHYSMOGRAPHY; PRIORITY JOURNAL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCLEROTHERAPY; SCORING SYSTEM; STATISTICAL ANALYSIS; ULTRASOUND GUIDED FOAM SCLEROTHERAPY; VARICOSIS; VEIN INSUFFICIENCY; VENOUS CLINICAL SEVERITY SCORE; VENOUS FILLING INDEX; COMPARATIVE STUDY; DIAGNOSTIC IMAGING; ECHOGRAPHY; ENDOVASCULAR SURGERY; LOW LEVEL LASER THERAPY; METHODOLOGY; OUTCOME ASSESSMENT; PHLEBOTOMY; PROCEDURES; SAPHENOUS VEIN; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ENDOVASCULAR PROCEDURES; FEMALE; HUMANS; LASER THERAPY; MALE; PATIENT OUTCOME ASSESSMENT; PHLEBOTOMY; PLETHYSMOGRAPHY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAPHENOUS VEIN; SCLEROTHERAPY; SEVERITY OF ILLNESS INDEX; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME; ULTRASONOGRAPHY; VENOUS INSUFFICIENCY;

EID: 85054874681     PISSN: 10785884     EISSN: 15322165     Source Type: Journal    
DOI: 10.1016/j.ejvs.2018.09.013     Document Type: Article

References (32)

1. Hamann, S.A.S., Giang, J., De Maeseneer, M.G.R., Nijsten, T.E.C., van den Bos, R.R., Editor's choice - five year results of great saphenous vein treatment: a meta-analysis. Eur J Vasc Endovasc Surg 54 (2017), 760–770.
2. Kheirelseid, E.A.H., Crowe, G., Sehgal, R., Liakopoulos, D., Bela, H., Mulkern, E., et al. Systematic review and meta-analysis of randomized controlled trials evaluating long-term outcomes of endovenous management of lower extremity varicose veins. J Vasc Surg Venous Lymphat Disord 6 (2018), 256–270.
3. Launois, R., Health-related quality-of-life scales specific for chronic venous disorders of the lower limbs. J Vasc Surg Venous Lymphat Disord 3 (2015), 219–227 e1–3.
4. Catarinella, F.S., Nieman, F.H., Wittens, C.H., An overview of the most commonly used venous quality of life and clinical outcome measurements. J Vasc Surg Venous Lymphat Disord 3 (2015), 333–340.
5. Balint, R., Farics, A., Parti, K., Vizsy, L., Batorfi, J., Menyhei, G., et al. Which endovenous ablation method does offer a better long-term technical success in the treatment of the incompetent great saphenous vein? Review. Vascular 24 (2016), 649–657.
6. Lattimer, C.R., Azzam, M., Kalodiki, E., Shawish, E., Trueman, P., Geroulakos, G., Cost and effectiveness of laser with phlebectomies compared with foam sclerotherapy in superficial venous insufficiency. Early results of a randomised controlled trial. Eur J Vasc Endovasc Surg 43 (2012), 594–600.
7. van den Bos, R., Arends, L., Kockaert, M., Neumann, M., Nijsten, T., Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg 49 (2009), 230–239.
8. Garratt, A.M., Macdonald, L.M., Ruta, D.A., Russell, I.T., Buckingham, J.K., Krukowski, Z.H., Towards measurement of outcome for patients with varicose veins. Qual Health Care 2 (1993), 5–10.
9. Aber, A., Poku, E., Phillips, P., Essat, M., Buckley Woods, H., Palfreyman, S., et al. Systematic review of patient-reported outcome measures in patients with varicose veins. Br J Surg 104 (2017), 1424–1432.
10. Rutherford, R.B., Padberg, F.T. Jr., Comerota, A.J., Kistner, R.L., Meissner, M.H., Moneta, G.L., Venous severity scoring: an adjunct to venous outcome assessment. J Vasc Surg 31 (2000), 1307–1312.
11. Passman, M.A., McLafferty, R.B., Lentz, M.F., Nagre, S.B., Iafrati, M.D., Bohannon, W.T., et al. Validation of Venous Clinical Severity Score (VCSS) with other venous severity assessment tools from the American venous Forum, National Venous Screening Program. J Vasc Surg 54 (2011), S2–S9.
12. Allan, J.C., Volume changes in the lower limb in response to postural alterations and muscular exercise. S Afr J Surg 2 (1964), 75–90.
13. Lattimer, C.R., Azzam, M., Kalodiki, E., Geroulakos, G., Venous filling time using air-plethysmography correlates highly with great saphenous vein reflux time using duplex. Phlebology 29 (2014), 90–97.
14. Raju, S., Ward, M. Jr., Jones, T.L., Quantifying saphenous reflux. J Vasc Surg Venous Lymphat Disord 3 (2015), 8–17.
15. De Maeseneer, M., Pichot, O., Cavezzi, A., Earnshaw, J., van Rij, A., Lurie, F., et al. Duplex ultrasound investigation of the veins of the lower limbs after treatment for varicose veins - UIP consensus document. Eur J Vasc Endovasc Surg 42 (2011), 89–102.
16. Lattimer, C.R., Kalodiki, E., Azzam, M., Geroulakos, G., Validation of a new duplex derived haemodynamic effectiveness score, the saphenous treatment score, in quantifying varicose vein treatments. Eur J Vasc Endovasc Surg 43 (2012), 348–354.
17. Labropoulos, N., Tiongson, J., Pryor, L., Tassiopoulos, A.K., Kang, S.S., Ashraf Mansour, M., et al. Definition of venous reflux in lower-extremity veins. J Vasc Surg 38 (2003), 793–798.
18. Vickers, A.J., Altman, D.G., Statistics notes: analysing controlled trials with baseline and follow up measurements. Br Med J 323 (2001), 1123–1124.
19. Lattimer, C.R., Kalodiki, E., Azzam, M., Makris, G.C., Somiayajulu, S., Geroulakos, G., Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy. Int Angiol 32 (2013), 394–403.
20. Evans, C.J., Allan, P.L., Lee, A.J., Bradbury, A.W., Ruckley, C.V., Fowkes, F.G., Prevalence of venous reflux in the general population on duplex scanning: the Edinburgh vein study. J Vasc Surg 28 (1998), 767–776.
21. Yim, E., Vivas, A., Maderal, A., Kirsner, R.S., Neuropathy and ankle mobility abnormalities in patients with chronic venous disease. JAMA Dermatol 150 (2014), 385–389.
22. Lattimer, C.R., Kalodiki, E., Azzam, M., Geroulakos, G., Varicose veins and severity of chronic venous disorder. Acta Phlebologica 13 (2012), 93–99.
23. Lattimer, C.R., Kalodiki, E., Azzam, M., Geroulakos, G., Responsiveness of individual questions from the venous clinical severity score and the Aberdeen varicose vein questionnaire. J Vasc Surg 55 (2012), 298–299.
24. Staniszewska, A., Tambyraja, A., Afolabi, E., Bachoo, P., Brittenden, J., The Aberdeen varicose vein questionnaire, patient factors and referral for treatment. Eur J Vasc Endovasc Surg 46 (2013), 715–718.
25. Ward, A., Abisi, S., Braithwaite, B.D., An online patient completed Aberdeen Varicose Vein Questionnaire can help to guide primary care referrals. Eur J Vasc Endovasc Surg 45 (2013), 178–182.
26. Onida, S., Shalhoub, J., Moore, H.M., Head, K.S., Lane, T.R., Davies, A.H., Factors impacting on patient perception of procedural success and satisfaction following treatment for varicose veins. Br J Surg 103 (2016), 382–390.
27. Rolstad, S., Adler, J., Ryden, A., Response burden and questionnaire length: is shorter better? A review and meta-analysis. Value Health 14 (2011), 1101–1108.
28. Klem, T.M., Sybrandy, J.E., Wittens, C.H., Measurement of health-related quality of life with the Dutch translated Aberdeen Varicose Vein Questionnaire before and after treatment. Eur J Vasc Endovasc Surg 37 (2009), 470–476.
29. Browne, J.P., van der Meulen, J.H., Lewsey, J.D., Lamping, D.L., Black, N., Mathematical coupling may account for the association between baseline severity and minimally important difference values. J Clin Epidemiol 63 (2009), 865–874.
30. Marston, W.A., Vasquez, M.A., Lurie, F., Wakefield, T., Rabe, E., Shortell, C.K., et al. Multicenter assessment of the repeatability and reproducibility of the revised Venous Clinical Severity Score (rVCSS). J Vasc Surg Venous Lymphat Disord 1 (2013), 219–224.
31. Asbeutah, A.M., Riha, A.Z., Cameron, J.D., McGrath, B.P., Reproducibility of duplex ultrasonography and air plethysmography used for the evaluation of chronic venous insufficiency. J Ultrasound Med 24 (2005), 475–482.
32. Wittens, C., Davies, A.H., Baekgaard, N., Broholm, R., Cavezzi, A., Chastanet, S., et al. Editor's choice - management of chronic venous disease: clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 49 (2015), 678–737.