Breek, J.C.

de Vries, J.

Hamming, J.F.

English

Tilburg University Repository

    Tilburg UniversityThe Oslo Balloon Angioplasty versus Convervative Treatment Study (OBACT). The 2-years results of a single centre, prospective, randomised study in patients withintermittant claudicationBreek, J.C.; de Vries, J.; Hamming, J.F.Published in:European Journal of Vascular and Endovascular SurgeryPublication date:2007Document VersionPublisher's PDF, also known as Version of recordLink to publication in Tilburg University Research PortalCitation for published version (APA):Breek, J. C., de Vries, J., & Hamming, J. F. (2007). The Oslo Balloon Angioplasty versus ConvervativeTreatment Study (OBACT). The 2-years results of a single centre, prospective, randomised study in patients withintermittant claudication. European Journal of Vascular and Endovascular Surgery, 34(3), 378-378.General rightsCopyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright ownersand it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights.            • Users may download and print one copy of any publication from the public portal for the purpose of private study or research.            • You may not further distribute the material or use it for any profit-making activity or commercial gain            • You may freely distribute the URL identifying the publication in the public portalTake down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Download date: 27. Oct. 2022Eur J Vasc Endovasc Surg 34, 378e380 (2007)doi:10.1016/j.ejvs.2007.04.020, available online at http://www.sciencedirect.com onCORRESPONDENCEThe Oslo Balloon Angioplasty versus ConservativeTreatment Study (OBACT)dThe 2-years Results ofa Single Centre, Prospective, Randomised Study inPatients with Intermittent Claudication. Eur J VascEndovasc Surg 2007;33:3e12.Sir,We would like to complement dr. Nylænde et al.1 forthe clear design and the strict follow-up of their study.Unfortunately, the number of patients available foranalysis is small. More importantly, the authors haveerroneously used the SF-36 as a QoL measure. This in-strument has been developed as a measure of healthstatus and the risks of its misuse as a QoL measurehave been brought to attention.2 The CLAU-S shouldalso be regarded as a measure of health status ratherthan of QoL. Health status reflects patients’ function-ing, whereas QoL also reflects a person’s individualevaluation of functioning.2The authors estimated ‘‘QoL’’ to improve by 20%after conservative treatment and 40% after PTA. How-ever, they did not explain how they arrived at thesepercentages and what this would mean for the pa-tient. Since haemodynamic status has a weak relation-ship with walking ability and walking ability onlypartially predicts a patient’s QoL,3 the question ariseswhat the clinical relevance of the estimated improve-ments would be, even if these were statisticallysignificant.The putative ‘‘QoL’’ results are expressed in un-specified numbers instead of actual scores and are,therefore, difficult to interpret. There were changesin SF-36 scores from baseline results at 3 months,which disappeared at 12 months, but surprisingly,re-appeared for Physical Functioning after 24 months.This suggests an influence from non-studied variableson health status. A similar lack of clarity appears forthe CLAU-S scores showing differences for Pain andEvery day life. The meaning and interpretation ofthese differences are not commented.The authors calculated statistical differences in‘‘QoL’’ scores using the mean values of the twogroups, which illustrate a misunderstanding of theconcept of QoL. QoL is highly individual and1078–5884/000378 + 03 $32.00/0  2007 Published by Elsevier Ltd osumming scores from more than one person elimi-nates individual values. The use of paired t-tests, tocompare pre- and post-intervention scores withineach participant would have been more in agreementwith the concept of QoL.In conclusion, the study results confirm transientbenefits with respect to Physical Functioning andBodily Pain in the first months after PTA. Improvedhaemodynamics after PTA did not translate into mea-surable benefits with regard to the primary endpointsof the study at two years.J.C. Breek1,*, J. De Vries2, J.F. Hamming31Department of Surgery, Martini Hospital Groningen,The Netherlands2Department of Medical Psychology, Tilburg University,Tilburg, The Netherlands3Department of Surgery, Leiden, Leiden UniversityMedical Centre, The NetherlandsE-mail address: j.c.breek@mzh.nlReferences1 NYLÆNDE M, ABDELNOOR M, STRANDEN E, MORKEN B,SANDBÆK G, RISUM Ø et al. The Oslo Balloon Angioplastyversus Conservative Treatment Study (OBACT)dThe 2-yearsresults of a single centre, prospective, randomised study inpatients with intermittent claudication. Eur J Vasc EndovascSurg 2007;33:3e12.2 BREEK JC, DE VRIES J, VAN HECK GL, VAN BERGE HENEGOUWEN DP,HAMMING JF. Assessment of disease impact in patients with inter-mittent claudication: discrepancy between health status and qual-ity of life. J Vasc Surg 2005;43:443e450.3 BREEK JC, HAMMING JF, DE VRIES J, VAN BERGE HENEGOUWEN DP,VAN HECK GL. The impact of walking impairment, cardio-vascular risk factors, and co-morbidity on quality of life inpatients with intermittent claudication. J Vasc Surg 2002;36:94e99.Accepted 21 April 2007Available online 19 June 2007DOI of original article: 10.1016/j.ejvs.2006.08.007.*Corresponding author. J.C. Breek, Department of Surgery, MartiniHospital Groningen, van Swietenlaan 4, PO Box 30033, NL-9700RM Groningen, The Netherlands.n behalf of European Society for Vascular Surgery.

The Oslo Balloon Angioplasty versus Convervative Treatment Study (OBACT). The 2-years results of a single centre, prospective, randomised study in patients with intermittant claudication

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The Oslo Balloon Angioplasty versus Convervative Treatment Study (OBACT). The 2-years results of a single centre, prospective, randomised study in patients with intermittant claudication

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