Title: A programme of high priority systematic reviews in the diagnosis and treatment of Peripheral Vascular Disease: an NHS partnership with the Cochrane PVD Review Group.
Funder: Department of Health (England)

Abstract: 6. Details of proposed programme Background (1000 characters max):We will focus on three main areas each of which is associated with serious consequences such as amputation or death if left untreated. Abdominal Aortic Aneurysm (AAA) can cause death from massive internal bleeding. Each year 6000-10000 people in England and Wales are affected and in 2009 the English NHS AAA screening programme began screening men over the age of 65. 123 Venous Thromboembolism (VTE) includes deep venous thrombosis (DVT) and pulmonary embolism (PE). These are estimated to cause 25000 deaths annually. Many of these deaths are potentially preventable and VTE prevention is currently a top NHS priority.4567Peripheral Arterial Disease (PAD) is a manifestation of systemic arthrosclerosis. It can severely limit walking distance due to the onset of intermittent claudication (IC) and in more severe cases can lead to a lower limb amputation. PAD is also a marker of increased cardiac risk equivalent to the presence of angina.8910Our programme of systematic reviews has been designed to produce reliable information about the management of these conditions and is aimed at improving quality of patient care in the NHS. Theme and scope of proposed programme (1000 characters max):This programme of high priority systematic reviews will support the effective prevention diagnosis and treatment of AAA VTE and PAD for those delivering and receiving care in the NHS. Working in partnership with the Cochrane Peripheral Vascular Disease group we will produce;1.20 new reviews on AAA VTE and PAD including 13 on interventions (9 new titles 3 completions of on-going reviews and 1 umbrella review of interventions for IC) and 7 new diagnostic test accuracy reviews2.20 updates of interventions for AAA VTE and PAD including updates which are overdue due to lack of existing resources and/or are required before the key umbrella review of all interventions for IC can be completedWe have selected and prioritized new review where (i) consultation with NHS clinicians patients and managers has identified a need for evidence on effectiveness of specific health care interventions and tests (ii) there are no comparable reviews already available or in-progress either within Cochrane or elsewhere and (iii) reviews will inform policy including forthcoming guidelines planned by national bodies (e.g. NICE).Proposed reviews to be undertaken and/or updated and how the choice is justified in terms of NHS priorities (2000 characters max):AAANew Reviews(i)Treatments for prevention of AAA growth(ii)Treatment of vascular risk factors to reduce CV mortality in patients with AAA (iii)Percutaneous versus standard EVAR repair for AAA(iv)Endovascular repair of AAA*(v)Imaging modalities for endoleak detection (EVAR)† (vi)Follow-up imaging strategies after AAA stenting (EVAR) † Review Updates . (i)EVAR for ruptured AAA (ii)Treatment for small asymptomatic AAAVTENew reviews (i)Cancer screening in patients with spontaneous VTE(ii)VTE prophylaxis in patients undergoing day case surgery(iii)Duplex ultrasound for diagnosis of DVT† (iv)D-dimer tests for diagnosis of DVT† (v)D-dimer tests for diagnosis of PE† Review updates(i)Duration of treatment with vitamin K antagonists in symptomatic VTE(ii)Once versus twice daily low molecular weight heparin for the initial treatment of VTE (iii)Vitamin K antagonists or LMWH for the long term treatment of symptomatic VTE(iv)Home versus in-patient treatment for DVT(v)Surgery for deep venous incompetence PADNew reviews (i)Screening modalities/programmes for PAD(ii)Closure devices following peripheral endovascular interventions(iii)Below knee surgical interventions for IC (angioplasty stents cryoplasty atherectomy) (iv)Non-invasive tests for diagnosis of PAD† (v)Graft surveillance and detection of stenoses after peripheral bypass grafting† (vi) Umbrella review of surgical and non-surgical interventions for IC (viii) Endoluminal stents for femoral & popliteal artery occlusions*(ix) Endovascular stents for IC* Review updatesUpdates required for the umbrella review of interventions for IC (i) Angioplasty (versus non surgical management) for IC(ii) Stents for IC(iii) Cryoplasty for IC(iv) Atherectomy for IC(v) Brachytherapy for IC(vi) Anticoagulants (heparin low molecular weight heparin and oral anticoagulants) for IC(vii) Exercise for IC (viii) Homocysteine lowering interventions for PAD and bypass grafts (ix) Naftidrofuryl for IC (IPD review)(x) Omega-3 fatty acids for IC (xi) Prostanoids for IC(xii) Supervised versus non-supervised exercise therapy for IC (xiii) Vitamin E for IC *new reviews resulting from completion of on-going reviews which have ‘stalled’ due to lack of existing resources– all other new reviews are new titles†diagnostic test accuracy reviewOutline plan and timetable for undertaking reviews including how award would be used (eg. employment of new researchers) (2000 characters max):We will ensure the best methodological standards are adopted in the conduct of all the proposed systematic reviews by adopting the procedures issued by the Cochrane Collaboration. The award will be used to employ 2 researchers (1 FTE researcher; 1 0.5 FTE researcher and programme manager Dr Fay Crawford and a 0.1 statistician Dr Francesca Chappell) who have expertise in systematic reviews of effects and diagnostic test accuracy and who will either facilitate completion of reviews where authors are already identified ( by providing personal assistance with use of statistical packages any identified training or assistance with data extraction) and who will co-author new reviews with clinical reviewers. The funds will also support statistical expertise in the meta analysis of diagnostic test accuracy systematic reviews (Dr Chappell).Programme timetable The programme will commence in April 2011. The identification of new clinical and public partner co-authors to work with programme researchers on entirely new reviews and the development of protocols for the 7 new diagnostic tests accuracy reviews involving Drs Crawford Chappell the appointed NHS Research and Dr MacDonald will be an immediate priority. Diagnostic test accuracy reviews are complex undertakings and need to be processed through a slightly more complex editorial process than is required for reviews of interventions involving the Cochrane Diagnostic Test Accuracy Editorial Team (DTA ET) as well as the Cochrane PVD Review Group. The Cochrane DTA ET will advise the Review Group on the suitability of each proposed DTA review title peer review the protocol and assess the planned review methods and analysis. The DTA ET judge whether a DTA protocol and then the review are suitable for publication based on the quality of its methods reporting of results and appropriate interpretation. (Cochrane web site 2010). Once the 7 protocols are submitted to the DTA ET the researchers will begin work on the protocols for the new titles of review of interventions for AAA and PAD. We aim to have the DTA protocols and the majority of new intervention review protocols published in the Cochrane Library within 18 months of the start of the work. Likely yield of DTA studies which meet the eligibility criteriaFrom the non-Cochrane DTA systematic reviews previously cited in this application we are able to estimate the likely yield of studies which would meet the eligibility criteria; for example for DVT of the lower limb the yield will be in excess of 113 studies for ultrasonography the yield is likely to be in excess of 216. 467


Research activity codes: 6.4 SURGERY;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;3.3 NUTRITION AND CHEMOPREVENTION;6.1 PHARMACEUTICALS
Health categories: CARDIOVASCULAR