European Association for Endoscopic Surgery and other Interventional Techniques

EAES Guidelines subcommittee Projects

AGREE II Extension for Guidelines in Surgery

https://gap-project.org
The AGREE II Instrument

The Appraisal of Guidelines for REsearch & Evaluation (AGREE) Instrument is a tool developed to assess the quality of guidelines and minimize the issue of variability in guideline quality. The first version was developed in 2003 and an updated version AGREE II was announced in 2017. The AGREE Collaboration defined quality of guidelines as the confidence that the potential biases of guideline development have been addressed adequately and that the recommendations are both internally and externally valid, and are feasible for practice.

The purpose of the AGREE II, is to provide a framework to:

  1. Assess the quality of guidelines;
  2. Provide a methodological strategy for the development of guidelines;
  3. Inform what information and how information ought to be reported in guidelines.

AGREE II instrument consists of 23 key items that can be rated in the range 1-7 (1- strongly disagree, 7- strongly agree). Items are organized into 6 domains followed by overall assessment (rating the overall quality of guideline and its recommendation for use in practice):

Domain 1. Scope and Purpose
Domain 2. Stakeholder Involvement
Domain 3. Rigour of Development
Domain 4. Clarity of Presentation
Domain 5. Applicability
Domain 6. Editorial Independence

AGREE II is applicable for the assessment of the guideline quality by healthcare workers and policy makers but also for the development of the guidelines with high methodological and reporting quality by guideline developers and educators.

Guideline Assessment Project (GAP)

The development of the AGREE II Extension for Surgical Guidelines is organised as a three staged GAP (Guideline Assessment Project) led by international multidisciplinary and interdisciplinary collaborative research working group. The aim of GAP is to develop an evidence-based and consensus-informed AGREE II Extension for Surgical Guidelines.

GAP I

GAP I aimed to assess the quality of clinical practice guidelines in Surgery and to identify factors associated with quality.

The study was organised as a review of the clinical guidelines published from January 2008 to August 2017 at MEDLINE by major national and surgical organizations with an international scope.

The association between the number of guidelines published within the study period by a scientific organization, the presence of a guidelines committee, applying the GRADE methodology, consensus project design, and the presence of intersociety collaboration and guideline quality, assessed by AGREE II instrument, was investigated by two independent reviewers.

Ten surgical scientific organizations developed 67 guidelines over the study period. The median overall score using AGREE II tool was 4 out of a maximum of 7, whereas 27 (40%) guidelines were not considered suitable for use.

Guidelines produced by a scientific organization with an output of ≥9 guidelines over the study period [odds ratio (OR) 3.79, 95% confidence interval (CI), 1.01–12.66, P = 0.048], the presence of a guidelines committee (OR 4.15, 95% CI, 1.47–11.77, P = 0.007), and applying the GRADE methodology (OR 8.17, 95% CI, 2.54–26.29, P < 0.0001) were associated with higher odds of being recommended for use.
Link to the publication

GAP II

The second part focused on statistical calibration of the AGREE II instrument. We employed a series of statistical methods to explore reliability and internal consistency of the AGREE II instrument. We have finally drafted a modified AGREE II document on the basis of the outcomes of statistical models.

Statistical modelling showed that excluding five items from the original tool (items 1, 2, 5, 7 and 8) and rearranging the remaining items into four domains instead of six would enhance the instrument. We have finally drafted a modified AGREE II document for guidelines in surgery, on the basis of the outcomes of statistical models.

GAP III

The third part of the project aims to use the information from the previous GAP projects to develop the extension document using a structured Delphi process involving relevant stakeholders.

The executive group consists of surgeons, members of surgical quality and research boards, guideline developers, evidence synthesis experts, GRADE methodologists, biostatisticians, and 2 leads of the AGREE Group, divided into four working groups which have discussed the findings of previous work, defined the methodology and study design, and identified potential stakeholder groups to comprise the Delphi panel.

Following the Delphi process, the executive group will meet to discuss the findings and compose the first draft of the extension document, conduct its pilot testing and compose AGREE II extension statement and extension checklist.

The executive group will monitor the use of the extension document and appraise its applicability in surgical guidelines for a reasonable period of time after dissemination and will publish their findings. Following consideration of the outcomes, feedback, criticism, suggestions and new evidence in the field, the executive group will discuss the need for an update.


Living review of surgical guidelines

The EAES Consensus & Guideline Subcommittee has set as strategic goal the evidence-informed and transparent selection of future EAES guideline projects.

To this aim, we are operationalizing an annual systematic review and quality assessment of published surgical guidelines to identify relevant gaps.

Quality appraisal is performed using the AGREE II tool, a validated instrument endorsed by WHO, NICE and other major organizations.

In conjunction with an annual survey of EAES members, this process informs the selection of future EAES rapid guidelines.

The first survey of EAES members has been launched as part of the Survey on Awareness and Use of EAES Guidelines that took place in December 2018 and January 2019 and is available here.

Figure 1 Summary graph of topics prioritized by EAES members in 2019


EAES Guideline Development Manual

Primary strategic goals of the EAES Consensus & Guideline Subcommittee are the improvement of quality and standardization of methodology of EAES guidelines.

The Subcommittee aims at developing a Guideline Development Manual which will be used in future EAES guideline projects. It may also serve as a reference to other national and international organizations.

The Manual will be available through the EAES website in February 2020.


PAST PROJECTS

EAES Bariatric Guidelines 2020

Background: Surgery for obesity and metabolic diseases has evolved in the light of new scientifc evidence, long-term outcomes and accumulated experience. EAES has sponsored an update of previous guidelines on bariatric surgery.

Methods: A multidisciplinary group of bariatric surgeons, obesity physicians, nutritional experts, psychologists, anesthetists and a patient representative comprised the guideline development panel. Development and reporting conformed to GRADE guidelines and AGREE II standards.

Results: Systematic review of databases, record selection, data extraction and synthesis, evidence appraisal and evidence-to-decision frameworks were developed for 42 key questions in the domains: Indication; Preoperative work-up; Perioperative management; Non-bypass, bypass and one-anastomosis procedures; Revisional surgery; Postoperative care; and Investigational procedures. A total of 36 recommendations and position statements were formed through a modifed Delphi procedure.

Link to publication

Table 1. Summary of recommendations for bariatric surgery

Indication for bariatric surgery
Laparoscopic bariatric surgery should be considered for patients with BMI ≥40 kg/m2 and for patients with BMI ≥35-40 kg/m2 with associated comorbidities that are expected to improve with weight loss. Strong
Laparoscopic bariatric/metabolic surgery should be considered for patients with ≥BMI 30-35kg/m2 and type 2 diabetes and/or arterial hypertension with poor control despite optimal medical therapy. Strong
Preoperative work-up No recommendation can be made for either routine H. pylori eradication or no eradication prior to bariatric surgery on the basis of available evidence. Conditional for either intervention or comparator
Preoperative dietitian consultation should be considered for patients undergoing bariatric surgery. Strong
Esophagogastroscopy can be considered as a routine diagnostic test prior to bariatric surgery. Conditional
Psychological evaluation can be considered before bariatric surgery.A previous diagnosis of binge eating or depression may not be considered as an absolute contraindication to surgery. Conditional
Perioperative Screening for obstructive sleep apnea using the STOP-BANG criteria can be considered prior to bariatric surgery. Conditional
Perioperative CPAP should be considered in patients with severe obstructive sleep apnea syndrome who are undergoing bariatric surgery. Strong
No recommendation can be made on the dose and duration of pharmacological thromboprophylaxis in patients after bariatric surgery. Conditional for either intervention or comparator
Inferior vena cava filter is not recommended for thromboprophylaxis in patients undergoing bariatric surgery Strong
No recommendation for either an ERAS protocol or standard care can be made on the basis of available evidence. Conditional for either intervention or comparator
Perioperative multimodal analgesia with minimal opioid usage may be considered in patients undergoing bariatric surgery. Conditional
Non-bypass procedures Adjustable gastric banding surgeries are associated with a high rate of reoperations for complications or conversion to another bariatric procedure for insufficient weight loss in the long term. Position statement
Sleeve gastrectomy may be preferred over adjustable gastric banding for weight loss and control/resolution of metabolic comorbidities. Conditional
Sleeve gastrectomy may offer improved short-term weight loss and resolution of type 2 diabetes compared to gastric plication. No significant differences are observed at mid-term. Long-term comparative data on weight loss and metabolic effects are, however, lacking. Position statement
There is insufficient evidence to recommend routine stapler line reinforcement* to reduce the leak rate. Position statement
Staple line reinforcement* in sleeve gastrectomy should be considered to reduce the risk of perioperative complications**. Strong
A bougie size <36F compared to a bougie sized ≥36F  may be recommended for calibration in sleeve gastrectomy as it is associated with greater weight loss in the mid-term. Conditional
More extensive antral resection (2-3cm from the pylorus versus >5cm antral preservation) potentially offers greater weight loss in the short term without a significant increase in post-operative complications. Long term data are, however, lacking. Position statement
Bypass procedures RYGB should be preferred over adjustable gastric banding. Strong
RYGB results in greater weight loss and control/remission of insulin resistance and type 2 diabetes compared to gastric plication. Position statement
RYGB offers similar mid-term weight loss and control/remission of metabolic comorbidities compared to sleeve gastrectomy. Long-term comparative data are, however, lacking. Position statement
RYGB can be preferred over sleeve gastrectomy in patients with severe gastroesophageal reflux disease and/or severe esophagitis. Conditional
No recommendation for either BPD/DS or sleeve gastrectomy can be made on the basis of available comparative evidence. Conditional for either intervention or comparator
With regard to mid-term weight loss there is no difference between BPD/DS and RYGB. BPD/DS is superior to RYGB for control/remission of type 2 diabetes. Long-term comparative data are, however, lacking. Position statement
One anastomosis procedures OAGB may offer greater short-term weight loss compared to RYGB, gastric plication, adjustable gastric banding and sleeve gastrectomy. Long-term comparative data are, however, lacking. The effect on nutritional deficiencies remains controversial. Position statement
No recommendation on SADI-S compared with OAGB, BPD/DS, RYGB or sleeve gastrectomy can be made on the basis of available evidence. Conditional for either intervention or comparator
Revisional surgery No evidence-based criteria for indication to revisional bariatric/metabolic surgery are available to date. The panel advises that the clinical decision to proceed to revisional bariatric/metabolic surgery be based on a complete multidisciplinary assessment of the patient, as recommended for the primary procedure. Position statement
Postoperative care Scheduled multidisciplinary post-operative follow-up should be provided to every patient undergoing bariatric/metabolic surgery. Strong
Treatment with ursodeoxycholic acid could be considered during the weight loss phase to prevent gallstones formation. Conditional
Micro and/or macronutrients supplementation is recommended after bariatric surgery according to the type of the procedure and to the deficiencies documented during the follow-up. Strong
PPI therapy should be given to patients undergoing bypass procedures for the prevention of marginal ulcers Strong
Postoperative nutritional and behavioral advice should be provided to patients undergoing bariatric surgery. Strong
Pregnancy following bariatric surgery should be delayed during the weight loss phase Strong
Investigational procedures For duodenal-jejunal bypass sleeves, aspiration devices, gastric electrical stimulation, vagal blockade and duodenal mucosal resurfacing, the quality of evidence was too low to provide any recommendations. Position statement
Endoluminal suturing procedures may have a role in the treatment of patients with obesity with BMI < 40kg/m2. Position statement

Position statements do not constitute recommendations.

BMI: body mass index
CPAP: continuous positive airway pressure
ERAS: Enhanced recovery after surgery
BPD/DS: biliopancreatic diversion with duodenal switch
OAGB: one anastomosis gastric bypass
SADIS: single-anastomosis duodeno-ileal switch
PPI: proton pump inhibitor
*Buttress, glues, suturing, clips
**Overall mortality, bleeding

Figure 1

Evidence-based decision tree on the decision for bariatric surgery or conservative management. BMI: body mass index. BMI values are kg/m2. Thick arrows and frames, and bold fonts indicate strong recommendation.

Figure 2

Evidence-based decision tree for preoperative work-up. *Psychological evaluation should be performed when psychological disorders are suspected. Binge eating and depression might not be a contraindication for bariatric/metabolic surgery. Thick arrows and frames, and bold fonts indicate strong recommendation. Dotted arrows and frames indicate conditional recommendation for the intervention. Dashed arrows and frames indicate conditional recommendation against the intervention.

Figure 3

Evidence-based decision tree for anesthetic and perioperative management. CPAP: continuous positive airway pressure, IVCF: inferior vena cava filter, ERAS: Enhanced Recovery After Surgery. *with minimal use of opioids. Thick arrows and frames, and bold fonts indicate strong recommendation. Dotted arrows and frames indicate conditional recommendation for the intervention. Dashed arrows and frames indicate conditional recommendation against the intervention.

Figure 4

Evidence-based decision tree for the selection of operative approach. BPD/DS: biliopancreatic diversion with duodenal switch, AGB: adjustable gastric banding, GERD: gastroesophageal reflux disease, RYGB: Roux-en-Y gastric bypass. Thick arrows and frames, and bold fonts indicate strong recommendation. Dotted arrows and frames indicate conditional recommendation for the intervention. Dashed arrows and frames indicate conditional recommendation against the intervention.

Figure 5

Evidence-based decision tree for postoperative follow-up. PPI: proton pump inhibitor. Thick arrows and frames, and bold fonts indicate strong recommendation.


Survey on awareness and use of EAES guidelines

Over the past 25 years, the European Association for Endoscopic Surgery (EAES) has been issuing clinical guidance documents to aid surgical practice.

This project aimed to investigate the awareness and use of such documents among EAES members. We invited members of EAES to participate in a web-based survey on awareness and use of these documents. Post hoc analyses were performed to identify factors associated with poor awareness/use and the reported reasons for limited use.

Our findings are summarized in the graphs below.

Figure 1 Summary graph of the awareness of the guidelines/consensus reports published by EAES among EAES members

Figure 2 Summary graph of the use of the EAES practice guidelines/ consensus reports among EAES members

Figure 3 Summary graph of the reasons for non-routine use of the EAES practice guidelines/ consensus reports in the practice of the EAES members


Conceptual analysis of EAES guidance documents

In this project, we aimed to conceptually appraise the methodology of EAES clinical practice guidance documents.

We systematically searched PubMed using the search string (EAES[ti] OR (European Association for Endoscopic Surgery[ti])) AND (Consensus[ti] OR Guideline*[ti] OR Recommendation*[ti]).

We defined 5 key methodological features (systematic literature search, interdisciplinary panel, patient involvement, evidence rating, and link between evidence and recommendations) and we documented whether these features were present.

We categorized guidance documents according to their features and we aimed to identify distinct phases of development.

We identified 22 documents published between 1994 and 2019. Eight were classified as consensus reports and 14 as guidelines.

Three distinct phases of development were identified:

Phase 1, the Consensus phase: In the first phase, only consensus reports were developed, usually without systematic review, no interdisciplinary team, elementary evidence rating (based only on study design) and unclear link between evidence and recommendations.

Phase 2, the Guideline phase: The second phase was characterized by the development of exclusively guideline projects, employing some form of a systematic review, interdisciplinary teams, evidence rating based on study design and additional parameters (consistency of effects, study quality) of the Oxford criteria, and some link between evidence and recommendations.

Phase 3, the Transitional phase: Both consensus reports and guideline projects were developed in the third phase, with improved reporting of the systematic review process, interdisciplinary panels, evidence rating using the Oxford criteria, several elements of the GRADE methodology in two guidelines and some link between evidence and recommendations.

Table 1. Summary characteristics of clinical guidance documents published by EAES 

Year Topic First Author Self-definition  Method Systematic review  Inter-disciplinary team  Patient involvement  Rating the evidence  Link between evidence and recommen-dations 
 
1995 Cholecystectomy, appendectomy, hernia repair  E. Neugebauer Consensus Consensus No No No Yesa Unclear  First phase

 

1996 Antireflux surgery  E. Eypash Consensus Consensus No No No Yesa Unclear 
1998 Choledocholithiasis A. Paul Consensus Consensus No No No Yesa Unclear 
1999 Diverticular disease  L. Köhler Consensus Consensus No No No Yesa Unclear 
2001 Hernia repair  Prof. A. Fingerhut Consensus Consensus Yesc No No Yesa Unclear 
2002 Techniques for pneumoperitoneum J. Neudecker Guideline Guideline Yesd  Yes  No Yesb  Unclear  Second phase
2004 Quality of life after laparoscopic surgery Prof. D. Korolija Guideline Guideline Yesd  Yes  No Yesb  Yes
2004 Colon cancer Dr. R. Veldkamp Guideline Guideline Yese  No  No  Yesb  Yes
2005 Bariatric surgery S. Sauerland Guideline Guideline Yese  Yes No  Yesb  Yes
2006 Abdominal emergencies S. Sauerland Guideline Guideline Yesd  Yes No Yesb  Yes
2008 Splenectomy Dr.med. B. Habermalz Guideline Guideline Yese  Yes No Yese  Yes
2010 Innovation management Prof. E. Neugebauer Guidelinef Guideline Yese  Yes No Yesb  No
2011 Rectal cancer R.L. Siegel Guideline Guideline Yesc Yes No Yesb  Yes
2013 Groin hernia M.M. Poelman Consensus Consensus Yesc N/A No Yesb  Yes Third phase
2014 Gastroesophageal reflux disease Prof. K-H. Fuchs Guidelinef Guideline Yesc Yes No Yesb  Yes
2014 Robotic surgery Dr. A. Szold Consensus Consensus Yesc Yes No Yesb  Yes
2015 Early rectal cancer Prof. M. Morino Consensus Consensus Yesc Yes No Yesb  Yes
2016 Acute appendicitis Dr. M. Gorter-Stam Consensus Guideline Yesc N/A No Yesb  Yes
2017 Pancreatic neoplasms Prof. B. Edwin Consensus Guideline Unclear Yes No Yesb  Yes
2018 3D laparoscopic surgery Prof. A. Arezzo Consensus Guideline Yes Yes N/A Yesb  Yes
2019 Single-incision endoscopic surgery Prof. S. Morales Conde Consensus Guideline Yesc  N/A No Yesb  Yes
2019 Acute diverticulitis Prof. N. Francis Consensus Guideline Yesc  No No Yesb  Yes
aEvidence rating based on study design (e.g. RCT: level 1, cohort study: level 2, etc.)
bEvidence rating based on study design with additional considerations (i.e. inconsistency, study quality; i.e. the Oxford criteria)
cDefined as systematic review; no further information provided
dDefined as systematic review and provided some relevant information; no search terms, search syntaxes or study selection flowcharts provided
eSearch strategy (search terms or search syntaxes) provided; no study selection flowchart
fDefined as set of recommendations
N/A: not applicable 

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