Donagh Healy

The SCARE Statement: Consensus-based surgical case report guidelines

INTRODUCTION Case reports have been a long held tradition within the surgical literature. Reporting guidelines can improve transparency and reporting quality. However, recent consensus-based guidelines for case reports (CARE) are not surgically focused. Our objective was to develop surgical case report guidelines. METHODS The CARE statement was used as the basis for a Delphi consensus. The Delphi questionnaire was administered via Google Forms and conducted using standard Delphi methodology. A multidisciplinary group of surgeons and others with expertise in the reporting of case reports were invited to participate. In round one, participants stated how each item of the CARE statement should be changed and what additional items were needed. Revised and additional items from round one were put forward into a further round, where participants voted on the extent of their agreement with each item, using a nine-point Likert scale, as proposed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group. RESULTS In round one, there was a 64% (38/59) response rate. Following adjustment of the guideline with the incorporation of recommended changes, round two commenced and there was an 83% (49/59) response rate. All but one of the items were approved by the participants, with Likert scores 7-9 awarded by >70% of respondents. The final guideline consists of a 14-item checklist. CONCLUSION We present the SCARE Guideline, consisting of a 14-item checklist that will improve the reporting quality of surgical case reports.

The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery

INTRODUCTION The development of reporting guidelines over the past 20 years represents a major advance in scholarly publishing with recent evidence showing positive impacts. Whilst over 350 reporting guidelines exist, there are few that are specific to surgery. Here we describe the development of the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS We published our protocol apriori. Current guidelines for case series (PROCESS), cohort studies (STROBE) and randomised controlled trials (CONSORT) were analysed to compile a list of items which were used as baseline material for developing a suitable checklist for surgical cohort guidelines. These were then put forward in a Delphi consensus exercise to an expert panel of 74 surgeons and academics via Google Forms. RESULTS The Delphi exercise was completed by 62% (46/74) of the participants. All the items were passed in a single round to create a STROCSS guideline consisting of 17 items. CONCLUSION We present the STROCSS guideline for surgical cohort, cross-sectional and case-control studies consisting of a 17-item checklist. We hope its use will increase the transparency and reporting quality of such studies. This guideline is also suitable for cross-sectional and case control studies. We encourage authors, reviewers, journal editors and publishers to adopt these guidelines.

Preferred reporting of case series in surgery; the PROCESS guidelines

INTRODUCTION Case series have been a long held tradition within the surgical literature and are still frequently published. Reporting guidelines can improve transparency and reporting quality. No guideline exists for reporting case series, and our recent systematic review highlights the fact that key data are being missed from such reports. Our objective was to develop reporting guidelines for surgical case series. METHODS A Delphi consensus exercise was conducted to determine items to include in the reporting guideline. Items included those identified from a previous systematic review on case series and those included in the SCARE Guidelines for case reports. The Delphi questionnaire was administered via Google Forms and conducted using standard Delphi methodology. Surgeons and others with expertise in the reporting of case series were invited to participate. In round one, participants voted to define case series and also what elements should be included in them. In round two, participants voted on what items to include in the PROCESS guideline using a nine-point Likert scale to assess agreement as proposed by the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group. RESULTS In round one, there was a 49% (29/59) response rate. Following adjustment of the guideline with incorporation of recommended changes, round two commenced and there was an 81% (48/59) response rate. All but one of the items were approved by the participants and Likert scores 7-9 were awarded by >70% of respondents. The final guideline consists of an eight item checklist. CONCLUSION We present the PROCESS Guideline, consisting of an eight item checklist that will improve the reporting quality of surgical case series. We encourage authors, reviewers, editors, journals, publishers and the wider surgical and scholarly community to adopt these.

Ultrasound guidance for difficult peripheral venous access: systematic review and meta-analysis

Background Establishing intravenous access is often vital in an acute hospital setting but can be difficult. Ultrasound-guided cannulation increases success rates in prospective studies. However, these studies have often lacked a comparative group. This systematic review and meta-analysis aimed to determine the clinical effectiveness of Ultrasound-guided peripheral intravenous cannulation compared with the standard technique in patients known to have difficult access. Methods Electronic abstract databases, trial registries, article reference lists and internet repositories were searched using the following search terms: ‘peripheral venous cannulation’, ‘peripheral venous access’. Studies meeting the following criteria were included: randomised controlled trial patients of all ages who required peripheral intravenous access; interventions were Ultrasound-guided versus standard cannulation technique; patients were identified as having difficult venous access; inclusion of at least one defined outcome (procedural success time to cannula placement; number of attempts). Results 7 trials were identified (289 participants). Ultrasound guidance increases the likelihood of successful cannulation (pooled OR 2.42; 95% CI 1.26 to 4.68; p=0.008). There were no differences in time to successful cannulation, or number of percutaneous skin punctures. Conclusion Ultrasound guidance increases the likelihood of successful peripheral cannulation in difficult access patients. We recommend its use in patients who have difficult venous access, and have failed venous cannulation by standard methods. Further randomised controlled trials (RCTs) with larger sample sizes would be of benefit to investigate if Ultrasound has any additional advantages in terms of reducing the procedure time and the number of skin punctures required for successful venous cannulation.

A systematic review of spinal cord injury and cerebrospinal fluid drainage after thoracic aortic endografting

BACKGROUND The use of thoracic endovascular aneurysm repair (TEVAR) is increasing. Similar to open repair, TEVAR carries a risk of spinal cord ischemia (SCI). We undertook a systematic review to determine whether preoperative cerebrospinal fluid (CSF) drainage reduces SCI. METHODS PubMed, the Cochrane Library, and conference abstracts were searched using the keywords thoracic endovascular aortic repair, cerebrospinal fluid, spinal cord ischaemia, TEVAR, and aneurysm. Studies reporting SCI rates and CSF drain rates for TEVAR patients were eligible for inclusion. SCI rates across studies were pooled using random-effects modeling. Study quality was evaluated using the Downs and Black score. RESULTS Study quality was generally poor to moderate (median Downs and Black score, 9). The systematic review identified 46 eligible studies comprising 4936 patients; overall, SCI affected 3.89% (95% confidence interval, 2.95.05%-4.95%). Series reporting routine prophylactic drain placement or no prophylactic drain placement reported pooled SCI rates of 3.2% and 3.47%, respectively. The pooled SCI rate from 24 series stating that prophylactic drainage was used selectively was 5.6%. CONCLUSIONS Spinal chord injury is uncommon after TEVAR. The role of prophylactic CSF drainage is difficult to establish from the available literature. High-quality studies are required to determine the role of prophylactic CSF drainage in TEVAR.

Systematic review and meta-analysis of routine total body CT compared with selective CT in trauma patients

Background Full-body CT scanning is increasingly being used in the initial evaluation of severely injured patients. We sought to analyse the literature to determine the benefits of full-body scanning in terms of mortality and length of time spent in the emergency department (ED). Methods A systematic search of the Pubmed and Cochrane Library databases was performed. Eligible studies compared trauma patients managed with selective CT scanning with patients who underwent immediate full-body scanning. Using random effects modelling, the pooled OR was used to calculate the effect of routine full-body CT on mortality while the pooled weighted mean difference was used to analyse the difference in ED time. Results Five studies (8180 patients) provided mortality data while four studies (6073 patients) provided data on ED time. All were non-randomised cohort studies and were prone to several sources of bias. There was no mortality difference between groups (pooled OR=0.68; 95% CI 0.43 to 1.09, p=0.11). There was a significant reduction in the time spent in the ED when patients underwent full-body CT (pooled effect size of weighted mean difference=−32.39 min; 95% CI −51.78 to −13.00; p=0.001). Conclusions We eagerly await the results of randomised controlled trials. Firm clinical outcome data are expected to emerge in the near future, though data on cost and radiation exposure will be needed before definitive conclusions can be made.

The Role of N--Acetylcysteine in the Prevention of Contrast-Induced Nephropathy in Patients Undergoing Peripheral Angiography A Structured Review and Meta-Analysis

Contrast-induced nephropathy (CIN) is a leading cause of hospital-acquired acute kidney injury (AKI). N-acetylcysteine (NAC) was proposed as an effective preventative measure. As data in relation to the use of NAC for the prevention of CIN in peripheral angiography are lacking, a systematic review and meta-analysis were undertaken. A comprehensive search for the published and unpublished data was performed. Data were extracted from the eligible studies. Pooled odds ratios (ORs) were used to calculate the effect of NAC on CIN incidence. Pooled effect size estimates were used to calculate the effect of NAC on serum creatinine (SCr) postcontrast. Our results showed that NAC did not reduce CIN incidence (pooled OR 1.05; 95% confidence interval [CI] 0.38-2.88; P = .92) or the mean SCr levels (pooled weighted mean difference, 4.38; 95% CI 10.4-1.65; P = .15). In conclusion, insufficient evidence exists to recommend NAC for the prevention of CIN in patients undergoing peripheral angiography.

Role of Far Infra-Red Therapy in Dialysis Arterio-Venous Fistula Maturation and Survival: Systematic Review and Meta-Analysis

Introduction A well-functioning arteriovenous fistula (AVF) is the best modality for vascular access in patients with end-stage renal disease (ESRD) requiring haemodialysis (HD). However, AVFs’ main disadvantage is the high rate of maturation failure, with approximately one third (20%–50%) not maturing into useful access. This review examine the use of Far-Infra Red therapy in an attempt to enhance both primary (unassisted) and secondary (assisted) patency rates for AVF in dialysis and pre-dialysis patients. Method We performed an online search for observational studies and randomised controlled trials (RCTs) that evaluated FIR in patients with AVF. Eligible studies compared FIR with control treatment and reported at least one outcome measure relating to access survival. Primary patency and secondary patency rates were the main outcomes of interest. Results Four RCTs (666 patients) were included. Unassisted patency assessed in 610 patients, and was significantly better among those who received FIR (228/311) compared to (185/299) controls (pooled risk ratio of 1.23 [1.12–1.35], p = 0.00001). In addition, the two studies which reported secondary patency rates showed significant difference in favour of FIR therapy- 160/168 patients - compared to 140/163 controls (pooled risk ratio of 1.11 [1.04–1.19], p = 0.003). Conclusion FIR therapy may positively influence the complex process of AVF maturation improving both primary and secondary patency rates. However blinded RCTs performed by investigators with no commercial ties to FIR therapy technologies are needed.

Effects of Neck Radiation Therapy on Extra-Cranial Carotid Arteries Atherosclerosis Disease Prevalence: Systematic Review and a Meta-Analysis

Introduction Radiation arteritis following neck irradiation as a treatment for head and neck malignancy has been well documented. The long-term sequelae of radiation exposure of the carotid arteries may take years to manifest clinically, and extra-cranial carotid artery (ECCA) stenosis is a well-recognised vascular complication. These carotid lesions should not be regarded as benign and should be treated in the same manner as standard carotid stenosis. Previous studies have noted increased cerebrovascular events such as stroke in this cohort of patients because of high-grade symptomatic carotid stenosis resulting in emboli. Aim To evaluate the effect of radiation therapy on ECCA atherosclerosis progression. Methods Online search for case-control studies and randomised clinical trials that reported on stenosis in extra-cranial carotid arteries in patients with neck malignancies who received radiation therapy (RT) comparing them to patients with neck malignancies who did not receive RT. Results Eight studies were included in the final analysis with total of 1070 patients – 596 received RT compared to 474 in the control group. There was statistically significant difference in overall stenosis rate (Pooled risk ratio  =  4.38 [2.98, 6.45], P  =  0.00001) and severe stenosis (Pooled risk ratio  =  7.51 [2.78, 20.32], P <0.0001), both being higher in the RT group. Pooled analysis of the five studies that reported on mild stenosis also showed significant difference (Pooled risk ratio  =  2.74 [1.75, 4.30], 95% CI, P  =  0.0001). Conclusion The incidence of severe ECCA stenosis is higher among patients who received RT for neck malignancies. Those patients should be closely monitored and screening programs should be considered in all patients who receive neck RT.

A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed.