Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial

Bradbury, Andrew W.; Adam, Donald J.; Bell, Jocelyn; Forbes, John F.; Fowkes, F. G. R.; Gillespie, Ian; Raab, Gillian M.; Ruckley, C. V.

doi:10.3310/hta14140

Cited by 148 publications

(120 citation statements)

References 203 publications

(225 reference statements)

Supporting

Mentioning

113

Contrasting

Unclassified

Order By: Relevance

“…On the other hand, our average in-hospital costs of endovascular treatment for CLI ($4 763.72 per year and $13.05 per day), resulting in individually different amputation-free survival periods, were lower than the threshold for the estimation of the cost-effectiveness of medical intervention for one QALY, as determined in Poland in January 2016 at the level of 345.08 PLN ($88.48) per day. This means that lower limb revascularization and salvation, even for a limited amputation-free survival period, should be recognized as a worthwhile and cost-effective procedure, which is supported by other authors [5,[9][10][11][12][13]. The resource expenditure linked with endovascular procedures might be further decreased by the selective use of stents and other expensive devices [9,14].…”

Section: Discussionmentioning

confidence: 82%

Koszty szpitalnego leczenia z powodu krytycznego niedokrwienia kończyn dolnych u pacjentów, u których ostatecznie przeprowadzono amputację kończyny. Obserwacje z jednego ośrodka

Budzyński¹,

Wnęk

Banaś

et al. 2017

MBS

View full text Add to dashboard Cite

S u m m a r y B a c k g r o u n d . Currently, the average amputation free survival in patients with critical limb ischemia (CLI) amounts to 76% after one year of follow-up. Such poor prognosis raises the question: is revascularization in patients with CLI cost-effective? The aim of this study was to conduct a cost analysis of vascular care in patients with CLI.The aim of this study was to conduct a cost analysis of vascular care in patients with CLI. P a t i e n t s a n d m e t h o d s . A retrospective cost analysis of in-hospital endovascular treatment in 37 patients with CLI who underwent secondary leg amputation between January 2012 and June 2015.R e s u l t s . The average length of time between the first endovascular procedure due to CLI and leg amputation amounted to 214 days (range 8-1088 days). The total cost of hospitalizations before leg amputation amounted to 687 603.13 PLN, which is, on average, 18 583.87 PLN per patient, and 86.84 PLN per person per day for living with the preserved lower limb. The total costs associated with the patients who had undergone leg amputation amounted to 404 883.24 PLN, which is an average of 10 942.79 PLN per patient. Previous endovascular procedures accounted for 58.9% of this sum and 37.1% to total management costs for the patients.C o n c l u s i o n s . The cost per day of endovascular treatment that makes it possible to live with two lower limbs did not exceed the established cost-effectiveness threshold. Lower limb amputation increases the costs of in-hospital patient care by 59%, represents financial wastage for the hospital, and incurs other costs not easily measured.S t r e s z c z e n i e W s t ę p . Obecnie około 76% pacjentów z krytycznym niedokrwieniem kończyn dolnych (KNKD) poddanych rewaskularyzacji przeżywa kolejny rok z zachowaną kończyną.Powstaje więc pytanie, czy zabiegi rewaskularyzacyjne u tych pacjentów są efektywne kosztowo, skoro 24% chorych nie korzysta z ich efektów dłużej niż przez rok? Celem niniejszej pracy była analiza kosztów opieki naczyniowej u pacjentów z KNKD.P a c j e n c i i m e t o d y . Retrospektywna analiza kosztów szpitalnego leczenia angiologicznego KNKD u 37 pacjentów poddanych wtórnej amputacji kończyny w okresie 01.2012 -06.2015. W y n i k i . Średni okres między pierwszym zabiegiem rewaskularyzacyjnym a amputacją tej kończyny wynosił 214 dni (przedział 8-1088dni). Całkowite koszty hospitalizacji związanych z zabiegami wewnątrznaczyniowymi przed amputacją kończyny wyniosły 687 603,13PLN, co średnio na pacjenta daje 18 583,87 PLN, 86,84 PLN za jeden dzień i 18 578,5 PLN za potencjalny rok życia z kończyną. Na koszty te składały się koszty stałe oraz zmienne, związane DOI: http://dx.doi.org/10.12775/MBS.2016.029 Jacek Budzyński et al. 14 głównie z liczbą implantowanych stentów (n=59) i leczeniem trombolitycznym (n=6). Natomiast całkowity koszt hospitalizacji związanych z amputacją kończyny dolnej wynosił w badanej grupie 404 883.24 PLN, co daje średnio 10 942,79 PLN na pacjenta. Suma ta stanowiła 58,9% kosztów wcześniejszych...

show abstract

Section: Discussionmentioning

confidence: 82%

Koszty szpitalnego leczenia z powodu krytycznego niedokrwienia kończyn dolnych u pacjentów, u których ostatecznie przeprowadzono amputację kończyny. Obserwacje z jednego ośrodka

Budzyński¹,

Wnęk

Banaś

et al. 2017

MBS

View full text Add to dashboard Cite

show abstract

“…In surgery, these included different methods for performing tonsillectomy 290 and for reconstructive surgery for limb ischaemia. 338 Some were the first in a particular setting, mainly in general practice, while others were new diagnostic tests, 339 referrals for pain and for lumbar spine radiography, 340,341 and screening for atrial fibrillation.…”

Section: First In Classmentioning

confidence: 99%

Models and applications for measuring the impact of health research: update of a systematic review for the Health Technology Assessment programme

Raftery

Hanney

Greenhalgh

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

BackgroundThis report reviews approaches and tools for measuring the impact of research programmes, building on, and extending, a 2007 review.Objectives(1) To identify the range of theoretical models and empirical approaches for measuring the impact of health research programmes; (2) to develop a taxonomy of models and approaches; (3) to summarise the evidence on the application and use of these models; and (4) to evaluate the different options for the Health Technology Assessment (HTA) programme.Data sourcesWe searched databases including Ovid MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library from January 2005 to August 2014.Review methodsThis narrative systematic literature review comprised an update, extension and analysis/discussion. We systematically searched eight databases, supplemented by personal knowledge, in August 2014 through to March 2015.ResultsThe literature on impact assessment has much expanded. The Payback Framework, with adaptations, remains the most widely used approach. It draws on different philosophical traditions, enhancing an underlying logic model with an interpretative case study element and attention to context. Besides the logic model, other ideal type approaches included constructionist, realist, critical and performative. Most models in practice drew pragmatically on elements of several ideal types. Monetisation of impact, an increasingly popular approach, shows a high return from research but relies heavily on assumptions about the extent to which health gains depend on research. Despite usually requiring systematic reviews before funding trials, the HTA programme does not routinely examine the impact of those trials on subsequent systematic reviews. The York/Patient-Centered Outcomes Research Institute and the Grading of Recommendations Assessment, Development and Evaluation toolkits provide ways of assessing such impact, but need to be evaluated. The literature, as reviewed here, provides very few instances of a randomised trial playing a major role in stopping the use of a new technology. The few trials funded by the HTA programme that may have played such a role were outliers.DiscussionThe findings of this review support the continued use of the Payback Framework by the HTA programme. Changes in the structure of the NHS, the development of NHS England and changes in the National Institute for Health and Care Excellence’s remit pose new challenges for identifying and meeting current and future research needs. Future assessments of the impact of the HTA programme will have to take account of wider changes, especially as the Research Excellence Framework (REF), which assesses the quality of universities’ research, seems likely to continue to rely on case studies to measure impact. The HTA programme should consider how the format and selection of case studies might be improved to aid more systematic assessment. The selection of case studies, such as in the REF, but also more generally, tends to be biased towards high-impact rather than low-impact stories. Experience for other industries indicate that much can be learnt from the latter. The adoption of researchfish®(researchfish Ltd, Cambridge, UK) by most major UK research funders has implications for future assessments of impact. Although the routine capture of indexed research publications has merit, the degree to which researchfish will succeed in collecting other, non-indexed outputs and activities remains to be established.LimitationsThere were limitations in how far we could address challenges that faced us as we extended the focus beyond that of the 2007 review, and well beyond a narrow focus just on the HTA programme.ConclusionsResearch funders can benefit from continuing to monitor and evaluate the impacts of the studies they fund. They should also review the contribution of case studies and expand work on linking trials to meta-analyses and to guidelines.FundingThe National Institute for Health Research HTA programme.

show abstract

“…The PaRADISE (Preventing Amputations Using DrugEluting Stents) [5] was the first non-randomised trial, in which a cohort of 106 patients treated with DES was prospectively studied and compared with historical data from the TASC II (Trans-Atlantic Inter-Society Consensus II) document and level-1 evidence from the BASIL (Bypass versus angioplasty in severe ischaemia of the leg) trial [5,12,13]. Primary endpoints were rates of limb salvage, amputation and major adverse events after 3 years of follow-up.…”

Section: Drug-eluting Stent (Des)mentioning

confidence: 99%

“…On the basis of these randomised controlled trials and other published studies [5,[9][10][11][12][13][14][15], features of DESs for below-theknee lesions may be summarised as follows:…”

Section: Drug-eluting Stent (Des)mentioning

confidence: 99%

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Fanelli

Cannavale

2014

Eur Radiol

View full text Add to dashboard Cite

To analyse data comparing drug-eluting devices versus non-coated devices in the treatment of vascular disease in the infrapopliteal region. All data available in the literature (16 studies were included) comparing drug-eluting stents (DESs) and drug-eluting balloons (DEBs) versus bare-metal stents (BMSs) and conventional balloons were analysed. For each single study, primary and secondary endpoints were reported. As comparative studies between DEBs and DESs were not available, a technical evaluation of the advantages and disadvantages of both were also included. Besides the limitations of the published studies, all of them were reporting interesting results for the new generation devices (DEB and DES). DES: primary patency at 1 year comprised between 75.0 % and 86 %; target lesion revascularisation between 8.7 % and 13.8 %. DEB: primary patency comprised between 71 % and 84.6 % at 12 months; target lesion revascularisation between 15.3 % and 17.6 %. However, limb salvage rates were not always higher using a DEB rather than a standard percutaneous transluminal angioplasty (PTA); a clinical improvement for patients treated with DEB was demonstrated only in the Leipzig registry. On the basis of the results available, the drug-eluting devices produced better results. DEB can be considered the leading approach in below-the-knee disease. A comparative evaluation with DES is mandatory in the future. Key Points • We present data about advanced endovascular treatment of peripheral artery disease.• This provides an update on drug-eluting devices in infrapopliteal vascular disease.• Drug-eluting devices (DEB/DES) show promising results compared with traditional ones.Abbreviations BMS bare-metal stent DEB drug-eluting balloon DES drug-eluting stent PTA percutaneous transluminal angioplasty SFA superficial femoral artery

show abstract

Multicentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial

Abstract: Current Controlled Trials ISRCTN45398889.

Cited by 148 publications

References 203 publications

Koszty szpitalnego leczenia z powodu krytycznego niedokrwienia kończyn dolnych u pacjentów, u których ostatecznie przeprowadzono amputację kończyny. Obserwacje z jednego ośrodka

Koszty szpitalnego leczenia z powodu krytycznego niedokrwienia kończyn dolnych u pacjentów, u których ostatecznie przeprowadzono amputację kończyny. Obserwacje z jednego ośrodka

Models and applications for measuring the impact of health research: update of a systematic review for the Health Technology Assessment programme

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Contact Info

Product

Resources

About