Foot ulceration is a common complication of diabetes and is associated with high mortality and costs. The quality of evidence to inform clinical practice is limited, partly because clinical studies do not consistently report baseline participant characteristics. This study aimed to develop a core descriptor set (CDS), a minimum set of descriptors to be measured in all studies evaluating interventions for people with diabetes-related foot ulceration. A longlist of descriptors was generated through a systematic review of studies assessing interventions for diabetes-related foot ulcers, pre-registered with PROSPERO (CRD42019128250). The identified descriptors were then ranked based on perceived importance by healthcare professionals from different fields and geographical locations using a nine-point Likert scale in the first round of a Delphi survey. Using standardised criteria, descriptors without consensus were re-ranked in round two. Critical descriptors and those without consensus after the Delphi process were discussed in the consensus meeting to finalise the CDS. The systematic review yielded 95 candidate descriptors. The two Delphi rounds were completed by 102 and 69 healthcare professionals, respectively. The Delphi process identified 34 critically important descriptors and 13 descriptors without consensus, which were discussed in the consensus meeting. The ratified CDS included 28 descriptors across nine domains: demographic variables; individual factors; ulcer characteristics; limb characteristics; ongoing medical interventions; previous surgical interventions; medication history; biochemical measurements; and quality of life/function/symptoms. This CDS reflects characteristics important to health professionals and researchers when reporting clinical studies on diabetes-related foot ulceration. Its use will aid the reporting of future studies.

BACKGROUND:Cryopreserved allografts remain a viable option for infrainguinal revascularization in limb salvage when autologous veins are unavailable or prosthetic material is undesirable. Uncertainty persists regarding comparative outcomes by allograft type (arterial vs venous) and clinical indication (infectious vs noninfectious settings). This systematic review and meta-analysis summarizes outcomes and key evidence gaps. METHODS:A systematic search of studies reporting infrainguinal reconstructions with cryopreserved arterial or venous allografts was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (International Prospective Register of Systematic Reviews: CRD42024579097). Primary outcomes were 1-year primary patency, overall survival, and cumulative major amputation. Random-effects single-arm meta-analyses were performed with subgroup analyses by graft type and infection status. Risk of bias was assessed using Risk Of Bias In Nonrandomized Studies - of Interventions and certainty of evidence using Grading of Recommendation Assessment, Development, and Evaluation (GRADE). Secondary outcomes, including reintervention and graft-related complications, were narratively summarized. RESULTS:Forty-two studies (2,237 patients; 2,170 limbs) were included: 25 were at serious risk of bias and 17 at moderate. Pooled 1-year primary patency was 51.1% (95% confidence interval [CI] 40.9-61.4%), overall survival 85.0% (95% CI 81.1-88.9%), and cumulative major amputation 20.2% (95% CI 15.7-24.7%). Arterial grafts had higher patency (67.6%; 95% CI 54.3-80.9%) than venous (39.6%; 95% CI 30.2-49.0%). Reconstructions for infection had superior patency (70.4%; 95% CI 55.2-85.6%) compared with noninfectious indications (44.2%; 95% CI 32.8-55.5%). GRADE certainty was very low. CONCLUSION:Cryopreserved allografts enable limb salvage in complex chronic limb-threatening ischemia but show modest 1-year patency and substantial heterogeneity. Arterial conduit and use in infection were associated with superior early patency; robust comparative studies are required to optimize graft selection.

ObjectiveInternational health systems had the opportunity to assess the resilience of core health services to severe disruption following the onset of the COVID-19 pandemic. This paper examines the resilience of a core health service to shocks from COVID-19. We compare outcomes following emergency admissions in England during the second (Winter 2020/21) and third (Winter 2021/22) major waves of COVID-19 with the first wave and historic admissions from 2016 to 2019.MethodsThis cohort study included adult emergency admissions for five common acute surgical conditions: appendicitis, symptomatic gallstone disease, intestinal obstruction, symptomatic diverticular disease, and abdominal wall hernia in 122 acute hospital Trusts in England. Participants were 647,367 admissions in the hospital episode statistics (HES) inpatient database including 34,560 in the second wave and 36,628 in the third wave. Outcome was all-cause mortality at 90 days.ResultsThere were 1308 deaths in wave two (3.8% of admissions) and 1235 (3.4%) in wave three compared with 3431 (3.4%) in the historic cohort and 577 (4.7%) in wave one. Compared with pre-COVID admissions, we found weak evidence of increased mortality in the second wave. There was no evidence of increased mortality in the third wave, compared to historic cohorts the case-mix adjusted odds ratios were: appendicitis 0.96 (95% CI 0.49-1.87); gallstone disease 1.27 (95% CI 0.94-1.72); diverticular disease 1.04 (95% CI 0.79-1.36); hernia 1.06 (95% CI 0.76-1.47); and intestinal obstruction 1.02 (95% CI 0.87-1.19).ConclusionsBy the end of wave three, outcomes for emergency admissions with five common acute conditions had returned to pre-pandemic levels. Lessons learnt during the disruption of the first wave of COVID-19 helped the NHS in England adapt emergency surgical services during subsequent waves. These findings emphasise the importance of maintaining, or quickly restoring core service capacity to help patient outcomes return to pre-pandemic levels.

RATIONALE:Peripheral arterial disease (PAD) is a condition most commonly caused by atherosclerotic narrowing of lower limb arteries, resulting in intermittent claudication, chronic limb-threatening ischaemia or acute limb ischaemia. There are various treatment strategies, including atherectomy, a technique used during endovascular surgery where the atheroma is cut or ground away within the artery. Another procedure, such as balloon angioplasty, is often performed at the same time. The studies investigating atherectomy for PAD have all been small-scale, with varying methodologies and, as a result, it is unclear if atherectomy is a more effective treatment for PAD compared to more conventional treatments. Despite this, rates of atherectomy use are increasing, especially in the United States. This review focuses on randomised controlled trials and is the second update of a Cochrane review, following the original publication in 2014 and the first update in 2020. OBJECTIVES:To evaluate the benefits and harms of atherectomy as a treatment for peripheral arterial disease compared to other treatments. SEARCH METHODS:We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from 13 August 2019 to 28 January 2025. ELIGIBILITY CRITERIA:We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or chronic limb-threatening ischaemia and evidence of atherosclerotic lower limb arterial disease. OUTCOMES:Outcomes of interest were: primary patency, all-cause mortality, fatal and non-fatal cardiovascular events, target vessel revascularisation rates and complication rates. RISK OF BIAS:We used the Cochrane risk of bias tool (RoB 1) to assess the risk of bias in the studies. We judged all included studies to have a high risk of overall bias. SYNTHESIS METHODS:Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used the GRADE criteria to assess the certainty of the evidence. Any disagreements were resolved through discussion. We synthesised results for each outcome using meta-analysis where possible (random-effects model, dichotomous outcomes assessed using the Mantel-Haenszel method, continuous outcomes assessed using the inverse variance method). INCLUDED STUDIES:We included 11 studies, with a total of 814 participants and 872 treated lesions. SYNTHESIS OF RESULTS:We found two comparisons: atherectomy versus balloon angioplasty (atherectomy versus BA) and atherectomy versus BA with primary stenting (atherectomy versus stenting). No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Ten studies (659 participants, 717 treated lesions) compared atherectomy versus BA. There was no evidence of differences between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.24, 95% confidence interval (CI) 0.92 to 1.68; 6 studies, 298 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.13, 95% CI 0.96 to 1.34; 5 studies, 326 participants; very low-certainty evidence); mortality rates (RR 0.50, 95% CI 0.24 to 1.02; 7 studies, 493 participants; very low-certainty evidence) or cardiovascular events at 12 months (RR 0.59, 95% CI 0.13 to 2.70; 2 studies, 163 participants; very low-certainty evidence). There was no evidence of differences when examining: six-month target vessel revascularisation (TVR) rates (RR 0.61, 95% CI 0.24 to 1.56; 5 studies, 348 treated vessels; very low-certainty evidence), 12-month TVR (RR 0.68, 95% CI 0.41 to 1.12; 6 studies, 371 treated vessels; very low-certainty evidence) or complication rates (RR 0.84, 95% CI 0.34 to 2.04; 7 studies, 457 participants; very low-certainty evidence). One study (155 participants, 155 treated lesions) compared atherectomy versus stenting, so the comparison was extremely limited and subject to imprecision. This study did not report primary patency. There was no evidence of a difference in the atherectomy versus stenting arms for mortality rates (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence), cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and TVR rates at six months (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence). The study did not report on TVR at 12 months. There was no evidence of a difference in complication rates between the two arms (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence). There are several limitations to the evidence. The studies were of small sample size, with poor methodological quality, considerable variations in protocols and a high overall risk of bias due to high attrition and a lack of blinding. AUTHORS' CONCLUSIONS:This review update shows that the evidence is still very uncertain about the effect of atherectomy on primary patency, mortality and cardiovascular event rates compared to plain balloon angioplasty with or without stenting alone. We identified no evidence of differences in target vessel revascularisation rates and complication rates, although this is again uncertain. The included studies were small, heterogeneous and at high risk of bias. Larger studies that are powered to detect clinically meaningful, patient-centred outcomes are required. FUNDING:This Cochrane review had no dedicated funding. REGISTRATION:Protocol and previous versions available via 10.1002/14651858.CD006680, 10.1002/14651858.CD006680.pub3.

OBJECTIVE:This focused update to the European Society for Vascular Surgery (ESVS) clinical practice guidelines (CPGs) on asymptomatic peripheral arterial disease and intermittent claudication (IC) provide revised recommendations on paclitaxel coated devices for endovascular infrainguinal interventions. Recent evidence, particularly from the SWEDEPAD 2 trial, prompted re-evaluation of their efficacy and potential long term risks. As the previously published guidelines were directed towards patients with Rutherford categories 0 - 3, the present update maintains the same scope. METHODS:A narrative systematic review assessed the benefits and risks of paclitaxel coated balloons and stents in infrainguinal revascularisation for IC. The ESVS Guidelines Writing Committee incorporated new randomised trial data into updated recommendations, graded according to the ESVS CPGs recommendation grading system. RESULTS:The updated evidence suggested limited clinical benefit and possible long term harm from paclitaxel coated devices in this population. SWEDEPAD 2 reported no improvement in quality of life (difference in six item Vascular Quality of Life Questionnaire [VascuQoL-6] score at 12 months was -0.02 [95% confidence interval -0.66 - 0.62], indicating no clinically relevant effect) or in reduced re-intervention at 12 months compared with uncoated devices, and indicated a potential excess in the long term all cause mortality rate. These findings corroborate earlier safety concerns raised in a 2018 meta-analysis and in subsequent pooled analyses. Recently published long term efficacy and safety data from some additional pivotal drug coated balloon trials were also considered but reported no or marginal clinical benefits. The update consistently emphasises supervised exercise therapy and best medical therapies as first line treatment. Endovascular revascularisation is recommended only for persistent lifestyle limiting symptoms despite conservative therapy. Paclitaxel coated devices may be considered only for selected cases with re-stenosis following transparent discussion of uncertain long term safety and, at best, modest symptomatic benefit. CONCLUSION:This ESVS focused update integrates emerging evidence to guide contemporary management of IC. Clinicians should carefully balance the limited short term procedural benefits of paclitaxel coated devices against the lack of proven quality of life improvement and the persisting uncertainty regarding long term mortality risk. Management of IC should follow a stepwise approach, prioritising lifestyle modification, exercise therapy, and optimal secondary preventive pharmacotherapy, with revascularisation reserved for compliant patients who remain significantly limited. Emphasis should be placed on conservative management, shared decision making, and continued research to further define the long term safety profile of paclitaxel coated endovascular devices.

Introduction E-cigarette use (often referred to as ‘vaping’) has increased rapidly over the past decade. Tobacco smoking is a well-established risk factor for adverse perioperative outcomes. While UK guidance supports e-cigarette use as a harm reduction and smoking cessation strategy, the perioperative implications of e-cigarette use are unclear. This scoping review aims to map the breadth and nature of the available evidence on e-cigarette use in the perioperative setting. It will describe how perioperative e-cigarette use is defined and measured, identify the perioperative populations and settings which have been studied, summarise reported perioperative outcomes and identify key knowledge gaps that should be addressed in future research.Methods and analysis This review will be conducted in accordance with Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines. MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Central, Web of Science and grey literature sources will be systematically searched from 2003, when the first commercially available e-cigarette was introduced, to February 2026. Studies will be screened, and data extracted by two independent reviewers. Studies of any design examining perioperative e-cigarette use in the perioperative period, across all surgical specialities, will be included. Data will be synthesised narratively and presented using tabular and visual summaries. The study will be undertaken between 9 February and 1 August 2026.Ethics and dissemination Ethical approval is not required for scoping reviews. Findings will be disseminated by conference presentation and publication in a peer-reviewed open-access journal and communication with stakeholders.

Background Wearable technologies have emerged as powerful tools in digital health and may improve monitoring and personalized care for patients with vascular diseases. However, their integration into routine vascular practice remains limited. This study aimed to evaluate the perceptions of vascular specialists regarding the potential clinical and research applications of wearable technologies in vascular surgery. Methods An international, cross-sectional web-based survey was conducted among health care professionals involved in vascular care across Europe. The questionnaire assessed participants’ demographic characteristics, prior experience with wearable devices, perceived clinical and research applications, and potential barriers to implementation. Descriptive statistics were used to summarize the responses. Results A total of 133 participants from 33 countries completed the survey. Most respondents were consultant vascular surgeons working in university or teaching hospitals. Overall, 36.1% reported prior experience with wearable technologies, most commonly smartwatches and activity trackers. Respondents identified potential benefits in chronic disease management (80.0%), perioperative monitoring (67.9%), telemedicine (67.2%), and secondary prevention (66.4%). A large majority (90.2%) agreed that wearable devices could support postoperative monitoring after vascular interventions. The most frequently reported barriers to implementation were device cost (71.8%), data security and privacy concerns (42.0% and 40.5%), time constraints (30.5%), and lack of validated devices (26.0%). Conclusion Vascular specialists recognize the potential of wearable technologies to enhance patient monitoring and support vascular research. Nevertheless, economic, technological, and regulatory challenges remain important barriers to their widespread implementation in vascular practice.

Background:Acute aortic syndrome is a life-threatening condition that requires urgent diagnosis with computed tomographic angiography. Diagnostic technologies, including clinical scores and biomarkers, can be used to select patients presenting with potential symptoms of acute aortic syndrome for computed tomographic angiography. Objectives:We aimed to estimate the accuracy of clinical scores and biomarkers for diagnosing acute aortic syndrome, the cost-effectiveness of alternative diagnostic strategies and the expected value of future research. Methods:We searched online databases from inception to February 2024, reference lists of included studies and existing systematic reviews. We included cohort studies evaluating the accuracy of clinical scores or biomarkers for diagnosing acute aortic syndrome compared with a reference standard. Two authors independently selected and extracted data. Risk of bias was appraised using the quality assessment of diagnostic accuracy studies-2 tool. Data were synthesised using either a multinomial or a bivariate normal meta-analysis model. We developed a decision-analytic model to simulate the management of a hypothetical cohort of patients attending hospital with possible acute aortic syndrome. We modelled diagnostic strategies that used the Aortic Dissection Detection Risk Score and D-dimer to select patients for computed tomographic angiography. We used estimates from our meta-analysis, existing literature and clinical experts to model the consequences of diagnostic strategies upon survival, health utility and healthcare costs. We estimated the incremental cost per quality-adjusted life-year gained by each strategy compared to the next most effective alternative on the efficiency frontier, and the expected value of perfect information. Results:Primary meta-analysis included 12 studies of Aortic Dissection Detection Risk Score alone, 6 studies of Aortic Dissection Detection Risk Score with D-dimer and 18 studies of D-dimer using the 500 ng/ml threshold. Sensitivities and specificities (95% credible intervals) were: Aortic Dissection Detection Risk Score > 0 94.6% (90% to 97.5%) and 34.7% (20.7% to 51.2%), Aortic Dissection Detection Risk Score > 1 43.4% (31.2% to 57.1%) and 89.3% (80.4% to 94.8%); Aortic Dissection Detection Risk Score > 0 or D-dimer > 500 ng/ml 99.8% (98.7% to 100%) and 21.8% (12.1% to 32.6%); Aortic Dissection Detection Risk Score > 1 or D-dimer > 500 ng/ml 98.3% (94.9% to 99.5%) and 51.4% (38.7% to 64.1%); Aortic Dissection Detection Risk Score > 1 or Aortic Dissection Detection Risk Score = 1 with D-dimer > 500 ng/ml 93.1% (87.1% to 96.3%) and 67.1% (54.4% to 77.7%); and D-dimer alone 96.5% (94.8% to 98%) and 56.2% (48.3% to 63.9%). We identified 11 cohort studies of other biomarkers, but accuracy estimates were limited and inconsistent. Decision-analytic modelling showed that applying diagnostic strategies to an unselected population (acute aortic syndrome prevalence 0.26%) resulted in high rates of computed tomographic angiography, and only the strategy selecting patients with Aortic Dissection Detection Risk Score > 1 for computed tomographic angiography was cost-effective. If clinicians can select a population for investigation with higher acute aortic syndrome prevalence (0.61%), then using a strategy of Aortic Dissection Detection Risk Score > 1 or Aortic Dissection Detection Risk Score = 1 with D-dimer > 500 ng/ml or a strategy of Aortic Dissection Detection Risk Score > 1 or D-dimer > 500 ng/ml to select patients for computed tomographic angiography is cost-effective and deliverable. At a threshold of £20,000/quality-adjusted life-year, population expected value of perfect information was around £17.75M. Limitations:Studies included in the meta-analysis showed substantial heterogeneity in estimates of specificity. In the modelling, there was substantial uncertainty around what constitutes suspected acute aortic syndrome and the effect of delayed diagnosis. Conclusions:The Aortic Dissection Detection Risk Score and D-dimer provide useful diagnostic information and may offer cost-effective strategies for selecting patients for computed tomographic angiography, but their role depends upon how clinicians identify suspected acute aortic syndrome. Future work:Primary research is required to compare different combinations of Aortic Dissection Detection Risk Score with D-dimer in practice, explore how suspected acute aortic syndrome is identified and evaluate alternative biomarkers. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR151853.

Objectives: To discover the maximum risk acceptable to patients and clinicians for complications typical to endovascular interventions in the setting of proximal deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS).Design: This was an observational study comparing patient/clinician risk acceptances in interviews using validated Standard Gamble methodology.Methods: 30 patients with previous DVT and 30 vascular clinicians were given a scenario describing a hypothetical case of a patient being managed with acute iliofemoral DVT and another with PTS. Subjects were asked to provide the maximum risk they would accept for individual complications to cure the condition. To interpret variability, the Venous Clinical Severity Score, SF-36 domains and VEINES-QoL for each patient were plotted against their risk acceptance for major bleeding in the DVT scenario.Results: For the DVT scenario, patients accepted high median risks compared to clinicians for major bleeding (40% vs 5%, p < .001), bleeding at other sites (50% vs 5%, p < .001), damage to blood vessels (60% vs 5%, p < .001), further procedures (80% vs 20%, p < .001), and treatment failure (75-80% vs 10-20%, p < .001). However, the gap was lower for intracranial bleeding (5% vs 1%, p = .004), pulmonary embolism (5 vs 5%, p = .39) or death (1% vs 0.75%, p = .77). For the PTS scenario, there were similar results again with a lower difference for pulmonary embolism (10% vs 5%, p = .02) and death (0.5% vs 1%, p = .72). Importantly, patient risk acceptance for major bleeding was negatively correlated to the emotional wellbeing (Rho = -0.43, p = .018) and social functioning (Rho = -0.38, p = .042) SF-36 domains.Conclusion: Overall, patients accepted a greater chance of most adverse events compared with clinicians. Patients prepared to accept greater risk were those with poorer emotional wellbeing and social functioning. It is important to take these issues into account when making shared decisions with patients about the management of their DVT/PTS.

BACKGROUND:The optimal use of ICU resources in patients undergoing vascular surgery is unclear. The aim of this systematic review was to evaluate the impact of ICU admission on clinical outcomes and costs after elective and emergency vascular surgery. METHODS:MEDLINE, Embase, the Cochrane Library, Cochrane Collaboration Central Register of Controlled Trials (CENTRAL), and trial registry databases were searched in July 2024. Studies comparing ICU care with intermediary or ward-based care for major vascular surgery patients were included. RESULTS:Thirteen studies (11 elective only and 2 including emergencies) involving 157 932 patients met the inclusion criteria. ICU admission was associated with higher adjusted 30-day or in-hospital mortality (OR 4.14 (95% c.i. 1.65 to 10.41), P = 0.003; Grading of Recommendations Assessment, Development, and Evaluation (GRADE) certainty: moderate). Unadjusted analyses found ICU admission was associated with increased major adverse cardiovascular events (risk ratio (RR) 1.45 (95% c.i. 1.04 to 2.01), P = 0.030; GRADE certainty: very low), acute kidney injury (RR 1.98 (95% c.i. 1.49 to 2.63), P < 0.001; GRADE certainty: moderate), dialysis (RR 1.76 (95% c.i. 1.13 to 2.74), P = 0.010; GRADE certainty: low), readmission (RR 1.93 (95% c.i. 1.20 to 3.12), P = 0.007; GRADE certainty: moderate), and major bleeding (RR 1.37 (95% c.i. 1.03 to 1.81), P = 0.030; GRADE certainty: moderate). Respiratory failure requiring mechanical ventilation and infection were higher in patients admitted to ICU compared with ward-based care specifically. Hospital-associated costs were higher for ICU admission across all procedures. CONCLUSION:No clear clinical benefit was associated with ICU admission after vascular surgery. This may be due to residual confounding and insufficient risk stratification.

Objective Inconsistencies in outcome data of therapeutic strategies for acute lower limb ischaemia (ALI) have hindered the synthesis of findings. A core outcome set (COS) may offer a solution to this problem by defining a minimum set of outcomes that are considered essential to all stakeholders involved. The first step in developing a COS is to review the previously reported outcomes on various treatment strategies for ALI. Data Sources PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched from inception to August 2023. Review Methods This systematic review was conducted in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative framework, adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was pre-registered with PROSPERO (CRD42022320073). Abstracts were independently screened by two authors for full text review. All outcomes and their definitions were extracted from selected papers. Outcomes with different terminologies were then categorised into an “agreed outcome term”. The list of agreed outcomes was given a standardised outcome domain and core area using a 38 item standardised taxonomy. Results Of 6 184 articles identified, 176 relevant studies were included, yielding 1 325 verbatim outcomes. After deduplication, 72 unique verbatim outcomes were categorised into five broad outcome domains. Outcomes considered key to the evaluation of treatment of ALI were further categorised as delivery of care (19.4%), vascular outcomes (13.8%), and adverse events (12.5%). The three most frequently reported agreed outcomes were amputation (14.1%), mortality (12.3%), and general bleeding (11.6%). Conclusion This systematic review provides an overview of currently reported outcomes in the literature of interventions for ALI. After categorisation into agreed outcome terms, 72 outcomes were identified that can be used in the development of a COS.

OBJECTIVE:Chronic venous disease (CVD) is a debilitating disease that results in significant morbidity and costs. A lack of standardised outcome reporting has made it difficult to evaluate the impact of interventions for CVD involving the deep veins. This study aimed to develop a core outcome set (COS) for studies evaluating interventions for this subset of CVD. METHODS:The COS was developed using the Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and interviews with 19 patients experiencing post-thrombotic syndrome after deep vein thrombosis generated a longlist of outcomes, which was then refined by a steering group. Each outcome was rated on importance by patients and healthcare practitioners using a 9 point Likert scale within a Delphi survey. Outcomes not meeting consensus criteria in the first round were re-prioritised in a second round. Outcomes meeting the criteria for being critically important were discussed in a final meeting between patients and international experts to develop the COS. RESULTS:The review and interviews generated 80 outcomes, which entered the Delphi process. In total, 233 stakeholders responded in the first round and 143 in the second round. Consensus was reached on 29 outcomes deemed critically important. These outcomes were discussed in the final meeting to yield seven general outcomes and six procedure specific outcomes, since some outcomes were not relevant to all patients with CVD. The general outcomes were death, lower limb ulceration, venous thromboembolism, bleeding, quality of life, limb pain, and oedema or limb swelling. The procedure specific outcomes were device migration, device mechanical failure, patency, technical and/or procedural success, re-intervention, and vascular complications. CONCLUSION:A COS was developed for studies evaluating interventions for CVD involving the deep veins, comprising seven general outcomes and six procedure specific outcomes. Reporting these outcomes will promote comparison of interventions for CVD involving the deep veins.

Foot complications are the most common cause of hospital admission of people with diabetes and a frequent cause of amputation. Neuropathy and peripheral arterial disease make the foot particularly vulnerable to ulceration, but infection is often the pathology precipitating presentation. Recognition of the patient at risk of ulceration may allow interventions to prevent the development of foot complications. When complications do occur, urgent treatment is required to prevent limb loss; the infected foot in a patient with diabetes is a surgical emergency. In addition to antibiotics, debridement and surgical drainage of infection should be considered within the first 24 hours after presentation. Once the foot is made safe, revascularization should be undertaken in those with significant arterial disease. Adoption of a multidisciplinary team approach to managing diabetic foot complications has resulted in reduction in major amputations in some European countries.

BACKGROUND:Pancreatic cancer is a leading cause of cancer-related death. Surgery (with systemic therapy) provides the only chance for long-term survival, but carries a high risk of morbidity and mortality. Robust evidence from meta-analyses, essential in informing decisions, is thwarted by inconsistencies between studies. This systematic review determines the nature and degree of heterogenous outcome reporting in research evaluating curative pancreatic cancer surgery. METHODS:A literature search of Medline, Embase, Cochrane Central and clinicaltrials.gov from 2017 to 2023 for eligible randomised and prospective studies adhering to a PROSPERO registered protocol. RESULTS:Included were 156 studies reporting a total of 2088 outcomes which deduplicated to 399 unique endpoints. No single outcome was reported in all studies. 45 % were not defined. Adverse events and delivery of care measures (typically technical aspects of surgery) accounted for 60 % and 32 % of outcomes respectively, compared to 6 % evaluating physical functioning post-surgery. CONCLUSION:The vast number and diversity of outcomes in use demonstrates lack of discernment in choice and disparity over domains of importance. Further work is needed to embed uniform outcome definitions, harmonise data collection and refocus research on fewer outcomes of proven relevance. Developing consensus on these critical outcomes through a Core Outcome Set is recommended.