Evidence Review Process - ESRA
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Laparoscopic Cholecystectomy 2017

Evidence Review Process

An explanation of PROSPECT methodology and Working Group processes can be found at the following link: PROSPECT methodology primer

For this laparoscopic cholecystectomy update review, the Subgroup members were:

W. H. Barazanchi1

S. MacFater1

J-L. Rahiri1

S. Tutone1

A. G. Hill1

G. P. Joshi2

  1. South Auckland Clinical School, University of Auckland, Department of Surgery, Middlemore Hospital, Auckland, New Zealand
  2. University of Texas Southwestern Medical Center, Anesthesiology and Pain Management, Dallas, TX, USA

Laparoscopic cholecystectomy update literature search

  • Systematic review of the literature August 2005 and December 2017 according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (Moher 2009)
  • Databases searched: EMBASE, MEDLINE, MEDLINE in process, Cochrane Central Register of Controlled Trials, Cochrane Database of Abstracts or Reviews of Effects, Cochrane Database of Systematic Reviews, and Cochrane NHS Economic Evaluation Database
  • Search terms were related to pain and interventions for laparoscopic cholecystectomy (Search strategy)
  • Inclusion criteria for studies were: RCTs and systematic reviews of analgesic, anaesthetic, and operative interventions, published in the English language, addressing pain management relating to excisional laparoscopic cholecystectomy. Included RCTs reporting pain scores using a linear pain scale, for example, VAS, VRS or NRS.
  • We excluded any studies on acute laparoscopic cholecystectomy. Studies that reported data pooled from patients undergoing mixed surgical procedures and laparoscopic cholecystectomy were also excluded
  • 1997 studies were identified, of which 258 RCT and 43 systematic reviews were selected
  • A total of 200 RCTs were used to justify the recommendations drafted in the published review, Barazanchi 2018 (Summary of literature selection)
  • The 258 identified studies examined a multitude of different interventions, some with only one supporting RCT. Hence, not all RCTs are referenced and used to formulate final recommendations in this review (Included studies)

Literature search history

The first PROSPECT review included 121 studies of interventions in laparoscopic cholecystectomy (published 1966 to October 2005) (McCloy 2008; also see Archived Laparoscopic Cholecystectomy 2005)

Assessments of the quality of study methodology and reporting

All included studies were assessed for quality of reporting of methodology using the PROSPECT Collaboration Methodology:

  1. Numerical scores (total 1–5) for study quality: assigned using the method proposed by Jadad and colleagues (Jadad 1996), to indicate whether a study reports appropriate randomisation, double-blinding, and statements of possible withdrawals
  2. Allocation concealment assessment: indicates whether there was adequate prevention of foreknowledge of treatment assignment by those involved in recruitment (A adequate, B unclear, C inadequate, D not used)
  3. Statistical analyses and patient follow-up assessment: indicates whether statistical analyses were reported, and whether patient follow-up was greater or less than 80%
  4. Additional study quality assessment: including an assessment of how closely the study report meets the requirements of the CONSORT (Consolidated Standards of Reporting of Trials) statement

The study quality assessments are summarised here: Methodological quality summary and Level of Evidence

  • Summary information for each included study was extracted and recorded in data tables. This information included pain scores, supplementary analgesic use, time to first analgesic request, functional outcomes, and adverse effects
  • It was assumed that the postoperative pain scores had been assessed at rest, unless otherwise specified in the study report
  • The systematic reviews were used to find additional studies via bibliographic screens and to aid in formulating recommendations
  • The included studies were grouped together based upon the analgesic technique (e.g. epidural analgesia, peripheral nerve blocks, field blocks, surgical site infiltration, paracetamol, NSAIDs, COX-2-specific inhibitors)
  • Within each analgesic group, the studies were further stratified into pre-operative, intra-operative, and postoperative interventions
  • The studies assessing the effects of surgical techniques on analgesic outcomes were grouped separately
  • The effectiveness of each intervention for each outcome was evaluated qualitatively, by assessing the number of studies showing a significant difference between treatment arms (p<0.05 as reported in the study publication)
  • Earlier PROSPECT methodology used ‘transferable evidence’ from similar procedures. Transferable evidence was not used in the current review.
  • Information on clinical practice was considered to ensure that the recommendations had clinical validity.
  • The recommendations were formulated by the interdisciplinary PROSPECT Working Group, using the Delphi method to collate rounds of individual comments on the evidence and draft recommendations, followed by round-table discussion, and then further Delphi rounds, to achieve final consensus
  • PROSPECT recommendations are based on clinical evidence, taking into account the risks and benefits of interventions as well as study design, including baseline analgesic technique, to determine the relevance of study interventions in current perioperative care practice
  • Recommendations for optimal pain relief are graded A–D according to the overall level of evidence, as determined by the quality of studies included, consistency of evidence and source of evidence: Relationship between quality and source of evidence, levels of evidence and grades of recommendation
  • The recommendations for this update review built on the recommendations for the previous review of postoperative pain management for laparoscopic cholecystectomy, which included 121 studies of interventions in laparoscopic cholecystectomy (published 1966 to October 2005) (McCloy 2008; also see Archived Laparoscopic Cholecystectomy 2005)

Limitations relate to the design of the included studies:

  • Available studies are of mixed methodological quality
  • Heterogeneity of included study methodologies precluded any useful meta-analyses of the available data
  • Many of the articles either did not state routine analgesic protocol or did not provide basic analgesia such as paracetamol or NSAID. Lack of routine analgesic protocol or inappropriate routine analgesia reduces the clinical relevance

The AGREE II instrument (Brouwers 2010) is used internationally to assess the methodological rigour and transparency of practice guidelines. As far as possible, the methodology of the PROSPECT Laparoscopic Cholecystectomy review meets the requirements of ‘Domain 3: Rigour of development’ of the AGREE II instrument:

  • Systematic methods were used to search for evidence.
  • The criteria for selecting the evidence are clearly described.
  • The strengths and limitations of the body of evidence are clearly described.
  • The methods for formulating the recommendations are clearly described.
  • The health benefits, side effects, and risks have been considered in formulating the recommendations.
  • There is an explicit link between the recommendations and the supporting evidence.
  • The guideline has been externally reviewed by experts prior to its publication. (The evidence and recommendations are made available on the website after peer review and publication)
  • A procedure for updating the guideline is provided. (Methodology is provided so that the systematic review can be updated as required)