Evidence Review Process - ESRA
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Oncological Breast Surgery 2019

Evidence Review Process

An explanation of PROSPECT methodology and Working Group processes can be found at the following link: https://esraeurope.org/prospect-methodology

 

For the breast surgery review, the Subgroup members were:

Aurelie Jacobs1

Adrien Lemoine2

Girish P. Joshi3

Marc Van de Velde4

Francis Bonnet5

 

  1. Resident, Department of Cardiovascular Sciences, KULeuven and University Hospital Leuven, Leuven, Belgium
  2. Consultant, Service D’Anethésie-Réamination et Médecine Péri-opératoire, Hopital Tenon, APHP, Paris, France/ Medécine-Sorbonne Université, Paris, France
  3. Professor, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, USA
  4. Professor, Department of Cardiovascular Sciences, KULeuven and University Hospital Leuven, Leuven, Belgium
  5. Professor, Service D’Anethésie-Réamination et Médecine Péri-opératoire, Hopital Tenon, APHP, Paris, France/ Medécine-Sorbonne Université, Paris, France

Breast surgery literature search

  • Systematic review of the literature associated with analgesia after breast surgery from 31 May 2006 to 15 October 2019
  • The following databases were searched: EMBASE, MEDLINE, PubMed and Cochrane Databases (Cochrane Central Register of Controlled Trials, Cochrane Database of Abstracts or Reviews of Effects, Cochrane Database of Systematic Reviews) (Search strategy)
  • Included studies were RCTs or systematic reviews in English assessing postoperative pain after oncological breast surgery using analgesic, anaesthetic or surgical interventions
  • Studies that reported pooled data from patients undergoing mixed procedures of cancer and non-cancer breast surgery were excluded
  • 143 studies were identified of which 69 were reviewed in more detail
  • 53 RCTs and 9 meta-analyses were included (Summary of literature selection; Included studies)
  • 7 studies were excluded after full-text screening
  • The reasons for exclusion were: not enough data collected for analysis (1) and no multimodal analgesia in control group (6)

Literature Search History

The first PROSPECT review included 42 studies of interventions in non-cosmetic breast surgery (published 1966 to May 2006) (archived on the website: Non-cosmetic Breast Surgery 2006)

Assessments of the quality of study methodology and reporting

All included studies were assessed for quality according to Prospect methodology (Joshi 2019, https://esraeurope.org/prospect-methodology). The study quality assessments for breast surgery are summarised here: Quality assessments and level of evidence

  • Data extraction and data analysis for breast surgery adhered to the PROSPECT methodology (Joshi 2019, https://esraeurope.org/prospect-methodology)
  • Pain intensity scores were used as the primary outcome measure
  • In this study, we defined a change of more than 10 mm on the VAS or NRS as clinically relevant
  • The effectiveness of each intervention for each outcome was evaluated qualitatively by assessing the number of studies showing a significant difference between treatment arms as reported in the study publication.
  • A meta-analysis was not performed due to heterogeneity in study design and result reporting, restricting pooled analysis.

Recommendations were made according to PROSPECT methodology (Joshi 2019, https://esraeurope.org/prospect-methodology). This involved a grading of A–D according to the overall level of evidence, as determined by the quality of studies included, consistency of evidence and study design: Relationship between quality and source of evidence, levels of evidence and grades of recommendation.

The proposed recommendations were sent to the PROSPECT Working Group for review and comments and a modified Delphi approach was used. Once a consensus was achieved the lead authors drafted the final document, which was ultimately approved by the working group.

The limitations of this review are related to those of the included studies:

  • Heterogeneity between studies, such as variable dosing regimens, methods of administration, a difference in the baseline analgesic management of control groups as well as variability in the time-points of pain assessments.
  • Small sample sizes of most studies, making it hard to draw firm conclusions concerning the side-effect profiles of analgesic interventions.

Future adequately powered studies should assess the effects of analgesic interventions not only on pain, opioid consumption, opioid-related adverse events and complications associated with the intervention but also outcome measures such as: time to ambulation; length of hospital stay; occurrence of opioid dependence; and patient-centred outcomes such as patient satisfaction or quality of recovery.

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 Breast Surgery 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)