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Objective Chronic limb threatening ischaemia (CLTI) is the most severe form of peripheral arterial disease. International guidelines recommend arterial revascularisation in patients with CLTI. However, these patients are often fragile elderly people with significant comorbidities, whose vascular anatomy is not always suitable for open or endovascular revascularisation. Recent studies have suggested acceptable outcomes of conservative treatment. A systematic review of the available literature was conducted to obtain best estimates of outcomes of conservative treatment in patients with CLTI. Data sources MEDLINE, Embase, and Cochrane Central. Review methods A systematic review and meta-analysis was carried out following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. MEDLINE, Embase, and Cochrane Central were searched from inception until September 2019. All studies reporting on outcomes of conservative treatment for CLTI were considered. Study selection, data extraction, and risk of bias assessment were done by two investigators independently. Risk of bias was evaluated with a modified version of the Cochrane tool for observational studies. Outcomes of interest were all cause mortality, major amputation, and amputation free survival (AFS) after at least 12 months of follow up. A random effects model was used for meta-analyses. Results Twenty-seven publications were included, consisting of 12 observational studies and 15 placebo arms from randomised clinical trials, totalling 1 642 patients. Most studies included patients with non-reconstructable CLTI. Overall study quality was moderate. The pooled 12 month all cause mortality rate in 14 studies comprising 1 003 patients was 18% (95% confidence interval [CI] 13 – 25, I2 = 73%). The pooled major amputation rate from 14 studies comprising 755 patients was 27% (95% CI 20 – 36, I2 = 65%) after one year, and pooled AFS rate after 12 months in 11 studies with 970 patients was 60% (95% CI 52 – 67, I2 = 75%). Conclusion Conservative treatment for patients with CLTI may be considered and does not always result in loss of limb or patient demise. The results of this review can be used to inform patients with CLTI about conservative treatment as part of a shared decision making process.

Accurate classification of diabetic foot ulcers is essential for inter-clinician communication, assessment of healing tendency and determination of treatment options. The aim of this study was to assess the inter-observer agreement (IOA) of the most commonly used classification systems for diabetic foot ulcers; the Meggitt-Wagner (MW) and the University of Texas (UT) systems. In this study, 95 clinicians judged digital photographs of diabetic foot ulcers in various stages of healing. Wound depth was classified along the grades of the MW and the UT systems. IOA of the MW and UT systems was only moderate among the clinicians. This moderate agreement demonstrates that the MW and the UT systems appear not to be useful as single instrument and should always be used in combination with additional clinical information to avoid erroneous interpretations.

Background The value of hyperbaric oxygen therapy (HBOT) in the treatment of diabetic ulcers is still under debate. Available evidence suggests that HBOT may improve the healing of diabetic ulcers, but it comes from small trials with heterogeneous populations and interventions. The DAMOCLES-trial will assess the (cost-)effectiveness of HBOT for ischemic diabetic ulcers in addition to standard of care. Methods In a multicenter randomized clinical trial, including 30 hospitals and all 10 HBOT centers in the Netherlands, we plan to enroll 275 patients with Types 1 or 2 diabetes, a Wagner 2, 3 or 4 ulcer of the leg present for at least 4 weeks, and concomitant leg ischemia, defined as an ankle systolic blood pressure of

We thank Drs. Mutluoglu (1) and Huang (2) for their critical comments. They both express concerns regarding our conclusion based on the results of the DAMO2CLES [Does Applying More Oxygen (O2) Cure Lower Extremity Sores?] trial that hyperbaric oxygen therapy (HBOT) does not confer benefit in the treatment of patients with ischemic foot ulcers and diabetes (3). During the course of the trial, lagging patient inclusion necessitated a downward adjustment of the sample size to meet the time limit imposed by the sponsor of the trial. Nevertheless, this trial still is the largest trial on HBOT in the treatment of ischemic ulcers and allows for future meta-analysis. Huang (2) was concerned about the variation in clinical practice. The common treatments for diabetic ischemic foot ulcers, such as wound management, vascular surgery, and total …

International guidelines recommend revascularisation as the preferred treatment for patients with critical limb ischaemia (CLI). Most contemporary research focuses on the outcome of invasive procedures for CLI, but little is known about the outcome of conservative management. Amputation free survival (AFS) and overall survival (OS) was investigated in patients with CLI who did or did not receive revascularisation, and characteristics associated with clinical outcomes were explored. This was a retrospective cohort study of consecutive patients with chronic CLI between 2010 and 2014 in a Dutch university hospital. CLI was defined as the presence of ischaemic rest pain or tissue loss in conjunction with an absolute systolic ankle pressure < 50 mmHg or a toe pressure < 30 mmHg. Patients were divided into invasive (revascularisation within 6 weeks), deferred invasive (revascularisation after 6 weeks), or permanently conservative treatment groups. Univariable and multivariable survival analyses were used to identify factors associated with AFS and OS. The majority (66.7%; N = 96) of the identified 144 patients with CLI (mean age 71.2 years; median follow-up 99 weeks) underwent revascularisation within 6 weeks of diagnosis. Deferred invasive treatment was provided in 18.1% (N = 26) patients and 22 patients (15.3%) were treated permanently conservatively. AFS and OS did not differ significantly between the three groups (Breslow-Wilcoxon p = .16 for AFS and p = .09 for OS). Age, chronic obstructive pulmonary disease (COPD), and heart disease were significant independent predictors of AFS. Age, COPD, and hypertension were significant independent predictors of OS. Treatment was not a significant predictor of either AFS or OS. Not all patients with CLI require revascularisation to achieve an AFS that is similar to patients undergoing revascularisation, although the efficacy of conservative versus invasive treatment in CLI patients is still unclear. Further prospective studies should determine subgroups of patients in whom revascularisation may be omitted

Objectives Shared decision making (SDM) is a process in which patients and their doctors collaborate in choosing a suitable treatment option by incorporating patient values and preferences, as well as the best available evidence. Particularly in vascular surgery, several conditions seem suitable for SDM because there are multiple treatment options. The objective of this study was to assess the degree of SDM behaviour in vascular surgery. Methods Vascular surgeons of four Dutch hospitals selected consultations with patients who were facing a treatment decision. Immediately after the consultation, patients and surgeons completed the (subjective) SDM Q-9 and SDM Q-doc questionnaires respectively, to appreciate the perceived level of SDM behaviour. Two evaluators independently and objectively rated SDM behaviour in the audiotaped consultations, using the Observing Patient Involvement (OPTION-12) scale. Results Nine vascular surgeons and three vascular surgeons in training conducted 54 consultations. The patients' median SDM Q-9 score was high, 93% (IQR 79–100%), and 16/54 (29.6%) of them gave the maximum score. The surgeons' median score was also high, 84% (IQR 73–92%), while 4/54 (7.4%) gave the maximum score. In contrast, mean OPTION score was 31% (SD 11%). Surgeons hardly ever asked the patients for their preferred approach to receive information, whether they had understood the provided information, and how they would like to be involved in SDM. Conclusions Currently, objective SDM behaviour among vascular surgeons is limited, even though the presented disorders allow for SDM. Hence, SDM in vascular surgical consultations could be improved by increasing the patients' and surgeons' awareness and knowledge about the concept of SDM.

Shared decision-making (SDM) invokes the bidirectional communication between physicians and patients required to involve the patient's preference in the eventual treatment choice. This paper will explain what SDM is, why it is important, and how it is performed in clinical practice. It is an essential part of evidence-based medicine, as it helps determine whether the available evidence on the possible benefits and harms of treatment options match the patient's characteristics and preferences. Cosmetic medicine and aesthetic surgery seem to be obvious fields of medicine in which SDM should be applied to achieve high-quality care.

BackgroundA pancreatoduodenectomy (PD) is a highly advanced procedure associated with considerable post-operative complications and substantial costs. In this study the hospital costs associated with complications after PD were assessed.MethodsA retrospective cohort study was conducted on 100 consecutive patients who underwent a pylorus-preserving (PP)PD between January 2012 and July 2013. Per patient, all complications occurring during admission or in the 30-day period after discharge were documented. All hospital costs related to the (PP)PD were defined as the costs of all medical interventions and resources during the hospitalisation period as recorded by the electronic supply tracking system.ResultsThe median hospital costs ranged from €17 482 for a patient without complications to €55 623 for a patient with a post-operative haemorrhage. A post-operative haemorrhage was associated with a 39.6% increase in total hospital costs after adjusting for patient characteristics. Other factors significantly associated with an increase in total hospital costs were: the presence of a malignancy other than a pancreatic adenocarcinoma (29.4% cost increase), the severity grade of a complication (34.3–70.6% increase) and the presence of a post-operative infection (32.4% increase).ConclusionsThis study provides an in-depth analysis of hospital costs and identifies factors that are associated with substantial cost consequences of specific complications occurring after a PD.

Background Foot ulceration is a major problem in people with diabetes and is the leading cause of hospitalisation and limb amputations. Skin grafts and tissue replacements can be used to reconstruct skin defects for people with diabetic foot ulcers in addition to providing them with standard care. Skin substitutes can consist of bioengineered or artificial skin, autografts (taken from the patient), allografts (taken from another person) or xenografts (taken from animals). Objectives To determine the benefits and harms of skin grafting and tissue replacement for treating foot ulcers in people with diabetes. Search methods In April 2015 we searched: The Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We also searched clinical trial registries to identify ongoing studies. We did not apply restrictions to language, date of publication or study setting. Selection criteria Randomised clinical trials (RCTs) of skin grafts or tissue replacements for treating foot ulcers in people with diabetes. Data collection and analysis Two review authors independently extracted data and assessed the quality of the included studies. Main results We included seventeen studies with a total of 1655 randomised participants in this review. Risk of bias was variable among studies. Blinding of participants, personnel and outcome assessment was not possible in most trials because of obvious differences between the treatments. The lack of a blinded outcome assessor may have caused detection bias when ulcer healing was assessed. However, possible detection bias is hard to prevent due to the nature of the skin replacement products we assessed, and the fact that they are easily recognisable. Strikingly, nearly all studies (15/17) reported industry involvement; at least one of the authors was connected to a commercial organisation or the study was funded by a commercial organisation. In addition, the funnel plot for assessing risk of bias appeared to be asymmetrical; suggesting that small studies with 'negative' results are less likely to be published. Thirteen of the studies included in this review compared a skin graft or tissue replacement with standard care. Four studies compared two grafts or tissue replacements with each other. When we pooled the results of all the individual studies, the skin grafts and tissue replacement products that were used in the trials increased the healing rate of foot ulcers in patients with diabetes compared to standard care (risk ratio (RR) 1.55, 95% confidence interval (CI) 1.30 to 1.85, low quality of evidence). However, the strength of effect was variable depending on the specific product that was used (e.g. EpiFix® RR 11.08, 95% CI 1.69 to 72.82 and OrCel® RR 1.75, 95% CI 0.61 to 5.05). Based on the four included studies that directly compared two products, no specific type of skin graft or tissue replacement showed a superior effect on ulcer healing over another type of skin graft or tissue replacement. Sixteen of the included studies reported on adverse events in various ways. No study reported a statistically significant difference in the occurrence of adverse events between the intervention and the control group. Only two of the included studies reported on total incidence of lower limb amputations. We found fewer amputations in the experimental group compared with the standard care group when we pooled the results of these two studies, although the absolute risk reduction for amputation was small (RR 0.43, 95% CI 0.23 to 0.81; risk difference (RD) -0.06, 95% CI -0.10 to -0.01, very low quality of evidence). Authors' conclusions Based on the studies included in this review, the overall therapeutic effect of skin grafts and tissue replacements used in conjunction with standard care shows an increase in the healing rate of foot ulcers and slightly fewer amputations in people with diabetes compared with standard care alone. However, the data available to us was insufficient for us to draw conclusions on the effectiveness of different types of skin grafts or tissue replacement therapies. In addition, evidence of long term effectiveness is lacking and cost-effectiveness is uncertain.

Objective A systematic review of randomized clinical trials (RCTs) to assess the additional value of hyperbaric oxygen therapy (HBOT) in promoting the healing of diabetic foot ulcers and preventing amputations was performed. Methods MEDLINE, Embase, and the Cochrane Library were searched to identify RCTs in patients with diabetic foot ulcers published up to August 2013. Eligible studies reported the effectiveness of adjunctive HBOT with regard to wound healing, amputations, and additional interventions. Results Seven of the 669 identified articles met the inclusion criteria, comprising 376 patients. Three trials included 182 patients with ischaemic ulcers, two trials studied 64 patients with non-ischaemic ulcers, and two trials comprising 130 patients did not specify ulcer type. Two trials were of good methodological quality. Pooling of data was deemed inappropriate because of heterogeneity. Two RCTs in patients with ischaemic ulcers found increased rates of complete healing at 1-year follow-up (number needed to treat (NNT) 1.8 (95% CI: 1.1 to 4.6) and 4.1 (95% CI: 2.3 to 19)), but found no difference in amputation rates. A third trial in ischaemic ulcers found significantly lower major amputation rates in patients with HBOT (NNT 4.2, 95% CI: 2.4 to 17), but did not report on wound healing. None of the RCTs in non-ischaemic ulcers reported differences in wound healing or amputation rates. Two trials with unknown ulcer types reported beneficial effects on amputation rates, although the largest trial used a different definition for both outcomes. HBOT did not influence the need for additional interventions. Conclusion Current evidence shows some evidence of the effectiveness of HBOT in improving the healing of diabetic leg ulcers in patients with concomitant ischaemia. Larger trials of higher quality are needed before implementation of HBOT in routine clinical practice in patients with diabetic foot ulcers can be justified.