Consensus Group Recommendations Research Articles

Anti-B-Cell-Activating Factor (BAFF) Therapy: A Novel Addition to Autoimmune Disease Management and Potential for Immunomodulatory Therapy in Warm Autoimmune Hemolytic Anemia.

Although rituximab is not specifically approved for the treatment of warm autoimmune hemolytic anemia (WAIHA), the First International Consensus Group recommends considering its use as part of the initial therapy for patients with severe disease and as a second-line therapy for primary WAIHA. Some patients do not respond to rituximab, and relapses are common. These relapses are associated with elevated B-cell-activating factor (BAFF) levels and the presence of quiescent long-lived plasma cells (LLPCs) in the spleen. A new group of immunomodulatory drugs, B-cell-activating factor inhibitors (BAFF-i), demonstrated efficacy in multiple autoimmune diseases and have the potential to improve WAIHA treatment outcomes by targeting B-cells and LLPCs. This article reviews the role of BAFF in autoimmune disorders and the currently available literature on the use of BAFF-directed therapies in various immunologic disorders, including WAIHA. Collectively, the clinical data thus far shows robust potential for targeting BAFF in WAIHA therapy.

Retreatment with Hyaluronic Acid Viscosupplementation in Knee Osteoarthritis: Agreement between EUROVISCO Guidelines and Current Medical Practice.

This work studied if and how current clinical practice agrees with European Viscosupplementation Consensus Group (EUROVISCO) recommendations and how this agreement might be different according to physician's specialization. In addition, this work aimed to identify key decision factors that practitioners consider in their decision to retreat or not a patient with hyaluronic acid viscosupplementation. Practitioners have been invited by e-mail to participate in an online exercise on viscosupplementation retreatment. They received a fictional patient case at random among a set of predefined fictional cases. The platform asked the practitioner if he/she would retreat the patient with viscosupplementation or not. To take a decision, the practitioner could select questions among a list of predefined questions. Among them, some were related to criteria used in the EUROVISCO decision tree and others served as confounding factors. A total of 506 practitioners participated to the exercise, of which 399 gave their decision about the case assigned to them by the platform. The observed agreement between practitioner decisions and EUROVISCO recommendations was 58.89 ± 4.95% (95% confidence interval [CI]). Overall, the decision to retreat was taken in 47.87% of the cases, while the EUROVISCO guidelines follow-up would have led to 55.89% retreatment for the same cases (P = 0.03). In current practice, physicians tended to reinject their patients less than recommended, although EUROVISCO guidelines for viscosupplementation retreatment consider decision criteria that clearly correspond to those of practitioners in real life. These include the patients' willingness to be treated or the patients' perception of the effectiveness of the treatment.

E.U. paediatric MOG consortium consensus: Part 5 - Treatment of paediatric myelin oligodendrocyte glycoprotein antibody-associated disorders.

In recent years, the understanding about the different clinical phenotypes, diagnostic and prognostic factors of myelin oligodendrocyte glycoprotein-antibody-associated disorders (MOGAD) has significantly increased. However, there is still lack of evidence-based treatment protocols for acute attacks and children with a relapsing course of the disease. Currently used acute and maintenance treatment regimens are derived from other demyelinating central nervous system diseases and are mostly centre-specific. Therefore, this part of the Paediatric European Collaborative Consensus attempts to provide recommendations for acute and maintenance therapy based on clinical experience and evidence available from mainly retrospective studies. In the acute attack, intravenous methylprednisolone (IVMP) leads to a favourable outcome in the majority of patients and can be followed by tapering of oral steroids up to a maximum of three months to maintain the benefit of acute treatment by suppressing disease activity. Intravenous immunoglobulins (IVIG) and plasmapheresis constitute second-line therapies in case of insufficient response to IVMP. After a first relapse, maintenance treatment should be started in order to prevent further relapses and the possibility of permanent sequelae. Four first-line therapies consisting of rituximab (RTX), azathioprine, mycophenolate mofetil or monthly IVIG have been identified by the consensus group. In case of further relapses despite maintenance treatment, the consensus group recommends treatment escalation with RTX or IVIG, followed by combining those two, and ultimately adding maintenance oral steroids. Many open questions remain which need to be addressed in further international prospective evaluation of MOGAD treatment. This international collaboration is essential to expand the state of current knowledge.

Scientific Review Committees as part of institutional review of human participant research: Initial implementation at institutions with Clinical and Translational Science Awards.

Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs). SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations. Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3weeks. For the 60% under review after 3weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures. The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.

Incidence and risk factors of readmission after esophagectomy for esophageal cancer.

The Esophageal Complications Consensus Group (ECCG) recommends that readmission to a primary or secondary hospital within 30 days of discharge after esophagectomy is an important quality outcome indicator for esophagectomy. This retrospective study was performed to investigate the incidence and risk factors for readmission after esophagectomy. We retrospectively reviewed 291 patients who received an esophagectomy and mediastinal lymphadenectomy for curative purposes from January 2006 to June 2017. The mean age was 63.02±8.02 years, and there were 264 (90.7%) male patients. Thirty-nine (13.4%) patients were re-admitted within 30 days after discharge. The mean interval from discharge to the readmission was 13.46±9.36. Common causes of readmission were anastomotic stricture that required ballooning (12, 30.7%), wound problem (7, 17.9%), pneumonia (6, 15.4%), and poor oral intake (4, 10.2%). Other causes of readmission were delayed gastric emptying [3], jejunostomy tube problem [2], ileus [2], pain [1], pneumothorax [1], and pleural effusion [1]. On multivariable analysis, anastomotic leakage (odd ratio =2.884, P=0.026) was significantly related to readmission, whereas age, pathologic stage, vocal cord palsy, and neoadjuvant therapy were not related to readmission. Readmission within 30 days after esophagectomy was determined to be related to postoperative anastomotic leakage and wound problems whereas the vocal cord palsy was not.

The Manchester International Consensus Group recommendations for the management of gynecological cancers in Lynch syndrome

PurposeThere are no internationally agreed upon clinical guidelines as to which women with gynecological cancer would benefit from Lynch syndrome screening or how best to manage the risk of gynecological cancer in women with Lynch syndrome. The Manchester International Consensus Group was convened in April 2017 to address this unmet need. The aim of the Group was to develop clear and comprehensive clinical guidance regarding the management of the gynecological sequelae of Lynch syndrome based on existing evidence and expert opinion from medical professionals and patients. MethodsStakeholders from Europe and North America worked together over a two-day workshop to achieve consensus on best practice. ResultsGuidance was developed in four key areas: (1) whether women with gynecological cancer should be screened for Lynch syndrome and (2) how this should be done, (3) whether there was a role for gynecological surveillance in women at risk of Lynch syndrome, and (4) what preventive measures should be recommended for women with Lynch syndrome to reduce their risk of gynecological cancer. ConclusionThis document provides comprehensive clinical guidance that can be referenced by both patients and clinicians so that women with Lynch syndrome can expect and receive appropriate standards of care.

Preventing infection from indwelling intravascular devices: Hospital infection society India consensus group recommendations for Indian healthcare

Preventing infection from indwelling intravascular devices: Hospital infection society India consensus group recommendations for Indian healthcare

Complications After Esophagectomy Are Associated With Extremes of Body Mass Index

Body mass index (BMI) is not routinely taken into consideration for risk stratification prior to esophagectomy. Extremes of BMI are associated with adverse surgical outcomes in a variety of surgical specialties. We assessed the relationship of BMI to outcomes after esophagectomy for cancer. Patients in the Society of Thoracic Surgeons General Thoracic Surgery Database (2009 to 2016) who underwent elective esophagectomy for cancer were selected for analysis. Open and minimally invasive approaches were included. Complications were categorized based on the Esophagectomy Complications Consensus Group recommendations. Multivariable logistic regression was used to adjust for confounding variables. We evaluated 9,389 patients grouped by BMI: underweight (<18.5 kg/m2; 3%), normal (18.5 to 24.9 kg/m2; 32%), overweight (25 to 29.9 kg/m2; 36%), obese I (30 to 34.9 kg/m2; 19%), obese II (35 to 39.9 kg/m2; 7%), and obese III (≥40 kg/m2; 3%). Most patients underwent open Ivor Lewis (33%), open transhiatal (23%), or minimally invasive Ivor Lewis (22%) approaches. The operative mortality rate was 3.4%; the frequency of complications by category ranged from 4% to 28%. On multivariable analysis, overall differences were identified among BMI categories for 7 out of 9 complication types. Underweight and obese III categories were associated with increased risk. In contrast, overweight and obese I BMI were associated with decreased risk for most complication types. BMI is associated with postoperative complications after esophagectomy. Postoperative risk assessment and prehabilitation regimens should be adjusted accordingly when planning an esophagectomy for a patient with very low or very high BMI.

Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions.

This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.

Outcome of a Step-Up Treatment Strategy for Chyle Leakage After Esophagectomy

Thoracic chyle leakage is a major complication of esophagectomy. In this study our treatment strategy for chyle leakage was evaluated and its risk factors were identified. According to the Esophagectomy Complications Consensus Group recommendations, chyle leakage was classified as follows: I, enteric dietary modifications; II, total parenteral nutrition (TPN); and III, interventional or surgical therapy. It was graded as A, less than 1,000 mL per day; or B, more than 1,000 mL per day. In our protocol, chyle leakage less than 500 mL per day was treated with a low-fat diet; more than 1,000 mL per day, with TPN, and 500 to 1,000 mL per day, with a low-fat diet or TPN depending on whether the chyle leakage was increasing or decreasing at diagnosis and the clinical condition. Surgery was reserved for refractory leakages. In total 371 patients were included. Chyle leakage incidence was 21%, consisting of 51% grade A and 49% grade B leakage. Chyle leakage severity was associated with length of stay (grade A, median 17 days versus B, 25 days; p= 0.006). Independent risk factors were a transthoracic approach (odds ratio 4.8, p= 0.002), neoadjuvant chemoradiotherapy (odds ratio 2.6, p= 0.002), and preoperative body mass index (exp(B) 0.92, p= 0.031). Treatment consisted of low-fat diet in 53%, TPN in 37%, and surgery in 10% of the patients. Low-fat diet and TPN successfully treated 87% of chyle leaks. Chyle leakages treated by TPN first were significantly more severe compared with those treated first by low-fat diet, and were significantly associated with electrolyte deficiencies, increased complication severity, and length of stay, but not with 90-day mortality. A step-up treatment strategy, starting with dietary modifications, solved nearly 90% of chyle leaks conservatively. A minority of chyle leaks required surgery.

Defining the distal margin of rectal cancer for surgical planning

Accurate measurement of the distal rectal tumor margin is essential in selecting the appropriate surgical procedure. However, there is no standard measurement method. The National Cancer Institute consensus group recommends use of the anal verge (AV) as a landmark, and the European Society of Gastrointestinal and Abdominal Radiology recommends use of the anorectal ring (ARR). In addition, whether measurements should be made on double contrast barium enema (BE) radiographs or magnetic resonance (MR) images remains controversial. We measured the distal tumor margin on both BE and MR images obtained preoperatively from 52 patients who underwent sphincter-saving resection for rectal cancer. The distances from the distal end of the tumor to the AV and the ARR were measured on both types of images, and the variability was investigated by Bland-Altman analysis. The mean distance from the tumor to the AV was 8.9 cm on the BE radiographs and 7.7 cm on the MR images (P=0.013). The mean distances to the ARR were 6.8 and 5.6 cm, respectively (P=0.070). Significant proportional bias was shown as the measured distances increased, the difference between the BE- and magnetic resonance imaging (MRI)-based measurements increased. Use of one or the other landmark did not affect selection of the appropriate surgical procedure. We conclude that an approximate 1-cm underestimation should be taken into account when MRI-based measurement of the distal rectal tumor margin is used to choose between sphincter-saving resection and abdominoperineal resection.

Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - A feasibility and safety study

BackgroundChronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion. MethodsWe included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed. ResultsThe recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p<0.001). There was no death or myocardial infarction. ConclusionsDrug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.

Use of Computed Tomography in Diagnosing Ventral Hernia Recurrence

Physical examination misses up to one-third of ventral hernia recurrences seen on radiologic imaging. However, tests such as computed tomographic (CT) imaging are subject to interpretation and require validation of interobserver reliability. To determine the interobserver reliability of CT scans for detecting a ventral hernia recurrence among surgeons and radiologists. We hypothesized there would be significant disagreement in the diagnosis of a ventral hernia recurrence among different observers. Our secondary aim was to determine reasons for disagreement in the interpretation of CT scans. One hundred patients who underwent ventral hernia repair from 2010-2011 at an academic health care center with a postoperative CT scan were randomly selected from a larger cohort. This study was conducted from July 2014 to March 2015. Prospective assessment of the presence or absence of a recurrent ventral hernia on CT scans was compared among 9 blinded reviewers and the radiology report. Five reviewers (consensus group) met to discuss all CT scans with disagreement. The discussion was assessed for keywords and key concepts. The remaining 4 reviewers (validation group) read the consensus group recommendations and reassessed the CT scans. Pre- and post-review κ were calculated; the post-review assessments were compared with clinical examination findings. Interobserver reliability in determining hernia recurrence radiographically. Of 100 CT scans, there was disagreement among all 9 reviewers and the radiology report on the presence/absence of a ventral hernia in 73 cases (κ = 0.44; 95% CI, 0.35-0.54; P < .001). Following discussion among the consensus group, there remained disagreement in 10 cases (κ = 0.91; 95% CI, 0.83-0.95; P < .001). Among the validation group, the κ value had a slight improvement from 0.21 (95% CI, 0.12-0.33) to 0.34 (95% CI, 0.23-0.46) (P < .001) after reviewing the consensus group proposals. There was disagreement between clinical examination and the consensus group assessment of CT scans on the presence/absence of a ventral hernia in 25 cases. The concepts most frequently discussed were the absence of an accepted definition for a radiographic ventral hernia and differentiating pseudorecurrence from recurrence. Owing to the high interobserver variability, CT scan was not associated with reliable diagnosing in ventral hernia recurrence. Consensus guidelines and improved communication between surgeon and radiologist may decrease interobserver variability.

Time to Endoscopy in Patients with Colorectal Cancer: Analysis of Wait-Times

Objective. The Canadian Association of Gastroenterology Wait Time Consensus Group recommends that patients with symptoms associated with colorectal cancer (CRC) should have an endoscopic examination within 2 months. However, in a recent survey of Canadian gastroenterologists, wait-times for endoscopy were considerably longer than the current guidelines recommend. The purpose of this study was to evaluate wait-times for colonoscopy in patients who were subsequently found to have CRC through the Division of Gastroenterology at St. Paul's Hospital (SPH). Methods. This study was a retrospective chart review of outpatients seen for consultation and endoscopy ultimately diagnosed with CRC. Subjects were identified through the SPH pathology database for the inclusion period 2010 through 2013. Data collected included wait-times, subject characteristics, cancer characteristics, and outcomes. Results. 246 subjects met inclusion criteria for this study. The mean wait-time from primary care referral to first office visit was 63 days; the mean wait-time to first endoscopy was 94 days. Patients with symptoms waited a mean of 86 days to first endoscopy, considerably longer than the national recommended guideline of 60 days. There was no apparent effect of length of wait-time on node positivity or presence of distant metastases at the time of diagnosis. Conclusion. Wait-times for outpatient consultation and endoscopic evaluation at the St. Paul's Hospital Division of Gastroenterology exceed current guidelines.

Guidelines for phototherapy of mycosis fungoides and Sézary syndrome: A consensus statement of the United States Cutaneous Lymphoma Consortium

Ultraviolet light (UVL) is a long established treatment for mycosis fungoides (MF) and Sézarysyndrome (SS), subtypes of cutaneous T-cell lymphoma (CTCL). Treatments have traditionally included broadband, narrowband ultraviolet B light (UVB) and psoralen plus ultraviolet A light photochemotherapy (PUVA), but more recently, treatment options have expanded to include UVA1 and excimer laser. UVL is used either as monotherapy or as an adjuvant to systemic therapy, demonstrating efficacy in many cases that equal or surpass systemic medications. Despite its utility and duration of use, the current practice of using UVL guidelines for psoriasis to treat patients with MF/SS is problematic because the goals of prolonging survival and preventing disease progression are unique to CTCL compared to psoriasis. We sought to develop separate guidelines for phototherapy for MF/SS for both clinical practice and for clinical trials. Literature review and cutaneous lymphoma expert consensus group recommendations. This paper reviews the published literature for UVB and UVA/PUVA in MF/SS and suggests practical standardized guidelines for their use. New standardization of phototherapy. These guidelines should allow the comparison of results with phototherapy in MF/SS acrossdifferent stages of patients, centers, and in combination with other agents in practice and in clinical trials.

Improved nutrient intake following implementation of the consensus standardised parenteral nutrition formulations in preterm neonates--a before-after intervention study.

BackgroundNew standardised parenteral nutrition (SPN) formulations were implemented in July 2011 in many neonatal intensive care units in New South Wales following consensus group recommendations. The aim was to evaluate the efficacy and safety profile of new consensus formulations in preterm infants born less than 32 weeks.MethodsA before-after intervention study conducted at a tertiary neonatal intensive care unit. Data from the post-consensus cohort (2011 to 2012) were prospectively collected and compared retrospectively with a pre-consensus cohort of neonates (2010).ResultsPost-consensus group commenced parenteral nutrition (PN) significantly earlier (6 v 11 hours of age, p 0.005). In comparison to the pre-consensus cohort, there was a higher protein intake from day 1 (1.34 v 0.49 g/kg, p 0.000) to day 7 (3.55 v 2.35 g/kg, p 0.000), higher caloric intake from day 1 (30 v 26 kcal/kg, p 0.004) to day 3 (64 v 62 kcal/kg, p 0.026), and less daily fluid intake from day 3 (105.8 v 113.8 mL/kg, p 0.011) to day 7 (148.8 v 156.2 mL/kg, p 0.025), and reduced duration of lipid therapy (253 v 475 hr, p 0.011). This group also had a significantly greater weight gain in the first 4 weeks (285 v 220 g, p 0.003).ConclusionsNew consensus SPN solutions provided better protein intake in the first 7 days and were associated with greater weight gain in the first 4 weeks. However, protein intake on day 1 was below the consensus goal of 2 g/kg/day.Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-014-0309-0) contains supplementary material, which is available to authorized users.

Melanoma: diagnosis, staging, and treatment. Consensus group recommendations.

The incidence of malignant melanoma is increasing worldwide. In Spain, its incidence is increasing faster than any other cancer type, with a 5-year survival rate of about 85%. The impact and characteristics of malignant melanoma in the Spanish population can be ascertained from the national melanoma registry of the Academia Española de Dermatología y Venereología. This review presents consensus group recommendations for the diagnosis, staging and treatment of malignant melanoma in Spain. Incidence and mortality are discussed, as well as evaluation of various prevention and treatment strategies. Prognostic factors, such as BRAF and C-KIT mutations, which are expected to become routine staging procedures over the next few years, are outlined, especially in relation to treatment options. The use of recently approved targeted agents such as ipilimumab, a cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) inhibitor, and vemurafenib, a BRAF inhibitor, in metastatic disease are also discussed.

Antiemetic recommendations for breast cancer patients receiving highly emetogenic chemotherapy: A systematic review incorporating network meta-analyses.

e17608 Background: Despite consensus group recommendations for anti-emetic use in patients receiving highly emetogenic anthracycline and cyclophosphamide-based chemotherapy (A and C-CT), clinical e...

Epidural and Continuous Wound Infusion in Enhanced Recovery Protocols

I read with interest the article by Jouve et al.1 comparing epidural analgesia with continuous wound infusion of local anaesthetic after fast-track colorectal surgery, and I would like to commend the authors on their thorough methodology.An important aspect of this trial is the management of patients within an enhanced recovery program, and the authors cite consensus recommendations, which guided to their management decisions.2 There are two areas that I feel the authors did not strictly adhere to the enhanced recovery recommendations. First, the consensus group recommends that the use of mechanical bowel preparation should be avoided except in the case of low rectal resections where diverting stomas are planned. However, patients receiving stomas were excluded and all patients undergoing left-sided or rectal resections received bowel preparation at the night before surgery. Second, all of the patients recruited to this study received large (19–20 cm) periumbilical midline incisions. Although it is true that the recommendations do not dictate the preference of transverse over midline incisions, they do recognize the findings of a Cochrane review reporting that short transverse incisions were associated with lower postoperative analgesic requirement and reduced pulmonary complications. My concern is that by including only the patients receiving midline incisions, they have selected a group that are more likely to benefit from epidural analgesia but do not represent the surgical population seen in other centers using enhanced recovery protocols.I also note the authors’ recognition of the potential bias resulting from early conclusion of the trial after interim analysis. This is of particular interest because a similar study recently completed in our institution recruited 60 patients, but did not reveal a significant difference in length of stay or dynamic pain scores between either epidural analgesia or continuous wound infusion.

The Problems of Using Unreliable Evidence in Consensus Group Decision-Making

Landoni and colleagues report the work of an International Consensus Group and present evidence-based non-surgical recommendations to reduce perioperative mortality.1Landoni G. Rodseth R.N. Santini F. Ponschab M. Ruggeri L. Székely A. et al.Randomized evidence for reduction of perioperative mortality.J Cardiothorac Vasc Anesth. 2012; 26: 764-772Abstract Full Text Full Text PDF PubMed Scopus (84) Google Scholar The International Consensus Group has recommended that aprotinin should not be used in cardiac surgery and cites as evidence the significant increase in mortality associated with aprotinin compared to the lysine analogues that was reported in the BART study.2Fergusson D.A. Hébert P.C. Mazer D. et al.A comparison of aprotinin and lysine analogues in high-risk cardiac surgery.NEJM. 2008; 358: 2319-2331Crossref PubMed Scopus (830) Google Scholar Ultimately, the quality of any recommendation depends on the quality of the evidence upon which it is made, and evidence from the BART study may be unreliable. Health Canada reviewed and re-analyzed the data from the BART study and, subsequently, so did the European Medicines Agency (EMA). Both drug regulatory agencies found concerning limitations to the published results regarding mortality.3Health Canada. Final report – expert advisory panel on Trasylol (aprotinin) 2011. Available from http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eap-gce_trasylol/final_rep-rap-eng.php (accessed 9 Oct 2012)Google Scholar, 4European Medicines Agency. European Medicines Agency recommends lifting suspension of aprotinin 2012. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/02/WC500122914.pdf (accessed 9 Oct 2012)Google Scholar After randomization, there had been an unexplained exclusion of 137 patients from the statistical analysis.3Health Canada. Final report – expert advisory panel on Trasylol (aprotinin) 2011. Available from http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eap-gce_trasylol/final_rep-rap-eng.php (accessed 9 Oct 2012)Google Scholar Most importantly, the mortality trend of these excluded patients was opposite to that of the included patients.3Health Canada. Final report – expert advisory panel on Trasylol (aprotinin) 2011. Available from http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eap-gce_trasylol/final_rep-rap-eng.php (accessed 9 Oct 2012)Google Scholar Reanalysis of the data including these originally excluded patients, reduced the mortality signal for aprotinin to statistically nonsignificant.3Health Canada. Final report – expert advisory panel on Trasylol (aprotinin) 2011. Available from http://www.hc-sc.gc.ca/dhp-mps/medeff/advise-consult/eap-gce_trasylol/final_rep-rap-eng.php (accessed 9 Oct 2012)Google Scholar Furthermore, the findings of the BART study have not been replicated; when data from other RCTs were analysed together with exclusion of data from the BART study, aprotinin was not associated with a higher risk of death compared with other antifibrinolytics.4European Medicines Agency. European Medicines Agency recommends lifting suspension of aprotinin 2012. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/02/WC500122914.pdf (accessed 9 Oct 2012)Google Scholar Given the major inaccuracies in the published paper that have been identified by Health Canada and the EMA, the International Consensus Group should not have considered the BART study to assess aprotinin as it has perversely influenced their decision making. Consensus groups and any other bodies making recommendations about clinical practice need to ensure that they use evidence of a reliable quality. Reply: Summarizing Randomized Evidence With Clinically Relevant Outcomes Performed in the Perioperative PeriodJournal of Cardiothoracic and Vascular AnesthesiaVol. 27Issue 3PreviewWe thank Drs Alston and McMullan1 for their comments and for the opportunity to better explain some aspects of the innovative2 paper that we recently published in JCVA.3 Full-Text PDF Randomized Evidence for Reduction of Perioperative MortalityJournal of Cardiothoracic and Vascular AnesthesiaVol. 26Issue 5PreviewWith more than 220 million major surgical procedures performed annually, perioperative interventions leading to even minor mortality reductions would save thousands of lives per year. This international consensus conference aimed to identify all nonsurgical interventions that increase or reduce perioperative mortality as suggested by randomized evidence. Full-Text PDF