Evidence Review Process - ESRA
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Laparoscopic Hysterectomy 2018

Evidence Review Process

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

For the laparoscopic hysterectomy review, the Subgroup members were:

Philipp Lirk MD PhD1

Juliette Thiry MD2

Marie Pierre Bonnet MD, PhD3

Girish P Joshi MBBS MD FFARCSI4

Francis Bonnet MD2

  1. Department of Anesthesiology, Perioperative and Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston MA, USA
  2. Department of Anesthesiology and Intensive Care Hôpital Tenon, Groupe Hospitalier Universitaire Est Parisien, Assistance Publique Hôpitaux de Paris, Université Pierre & Marie Curie, Paris VI, France
  3. Department of Anesthesiology and Intensive Care Hôpital Cochin, Assistance Publique Hôpitaux de Paris, Université René Descartes, Paris V, France
  4. Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas TX, USA

Laparoscopic hysterectomy literature search

  • Systematic review of the literature between January 1996 and May 2018 according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, from the EMBASE and MEDLINE databases, and the Cochrane register of controlled trials (Moher 2009) (Search strategy)
  • Included studies were RCTs assessing analgesic, anaesthetic, or surgical interventions for laparoscopic hysterectomy with pain intensity measured by VAS or NRS. Studies that did not measure pain intensity and studies including laparoscopic hysterectomy that reported data pooled with other surgical procedures were excluded
  • 281 studies were identified of which 74 were reviewed in more detail
  • 56 RCTs were included (Summary of literature selection; Included studies). Of these, 31 assessed analgesic or anaesthetic interventions and 25 assessed surgical interventions
  • 18 studies were excluded after full-text screening
  • The reasons for study exclusion were: no pain score (9), missing data (2), outside scope of this study (7)

Assessments of the quality of study methodology and reporting

All included studies were assessed for quality as explained below. The study quality assessments are summarised here: Methodological quality summary and level of evidence

The criteria used to assess the quality of eligible studies were:

  • Statistical analyses and patient follow-up assessment – indication of whether statistical analysis was reported and whether follow-up was more or less than 80 per cent of the patients
  • Allocation concealment assessment – indication of whether there was adequate guarantee of blinding for treatment assignment (A, adequate; B, unclear; C, inadequate; D, not used)
  • Quality of studies was graded using the Jadad numerical score (total 1–5) using the criteria based on appropriate randomization, double-blinding and statements of possible withdrawals (Jadad 1996)
  • The focus was on pain intensity whenever it was the primary or secondary outcome. Unless specified otherwise, it was assumed that pain scores were assessed at rest
  • Data on comparative opioid consumption were also retrieved, particularly when the study design included patient-controlled intravenous opioid (morphine or morphine equivalent) administration
  • The studies were stratified according to the intervention evaluated: analgesic, anaesthetic, or surgical
  • The effectiveness of each intervention was evaluated qualitatively by assessing the number of studies showing a significant difference
  • For the purpose of this review, we define a change >10 mm on a 100 mm VAS scale as clinically important (Myles 2017)

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 are given when at least two congruent studies support an intervention

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

Limitations relate to the design of the included studies:

  • Assessment of single interventions rather than multimodal analgesia
  • Heterogeneity in study design with respect to the analgesic regimen
  • Focus on assessment of pain at rest, without assessment of pain at activity
  • Too few patients included in studies of non-opioids to draw conclusions regarding their safety profile in the setting of laparoscopic hysterectomy
  • Small size of most studies supporting the opioid-sparing effect of non-opioids

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 Hysterectomy 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)