Evidence Review Process - ESRA
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Hallux Valgus Repair 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 hallux valgus repair surgery review, the Subgroup members were:

  • Katarzyna Korwin-Kochanowska*1
  • Arnaud Potié*2
  • Kariem El-Boghdadly3
  • Narinder Rawal4
  • Girish P. Joshi5
  • Eric Albrecht6
  1. Resident, Department of Cardiovascular Sciences and Department of Anesthesiology, University Hospitals of the KU Leuven, Belgium
  2. Consultant, Department of Anesthesia, University Hospital of Lausanne and University of Lausanne, Lausanne, Switzerland
  3. Consultant, Department of Anesthesia, Guy’s and St Thomas’ NHS Foundation Trust & King’s College London, London, United Kingdom
  4. Department of Anesthesiology and Intensive Care, University Hospital, Örebro, Sweden
  5. Professor, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, United States
  6. Program director of regional anesthesia, Department of Anesthesia, University Hospital of Lausanne and University of Lausanne, Lausanne, Switzerland

*Co-primary authors

Hallux valgus repair surgery literature search

  • Systematic review of the literature associated with analgesia after hallux valgus repair surgery from inception of database creation to 14th December 2019
  • The following databases were searched: the US National Library of Medicine Database (MEDLINE), the Excerpta Medica database (EMBASE), the Cochrane Databases of Systematic Reviews, the Cochrane Central Register of Controlled Clinical Trials, Cumulative Index of Nursing and Allied Health Literature (CINAHL), PubMed, and Web of Science (Search strategy)
  • Included studies were RCTs or systematic reviews in English assessing postoperative pain after hallux valgus repair surgery using analgesic, anaesthetic or surgical interventions
  • Excluded articles included any article describing a phase II study for a drug that was unlicensed at the time of this review, and any study that compared different agents, dosages, concentrations or analgesic techniques with no control group
  • Of 836 studies identified (835 from literature search + 1 from bibliography screening), 152 were reviewed in more detail
  • 55 RCTs and 1 systematic review met the inclusion criteria (Summary of literature selection; Included studies)
  • 96 studies were excluded after full-text screening (Excluded studies)
  • The reasons for exclusion were: no control group (n=21), not procedure-specific (n=44), no pain scores reported (n=20), no FDA approval (n=5), not RCT (n=2), other reasons (n=4)

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 hallux valgus repair surgery are summarised here: Quality assessments and level of evidence assigned to included trials

  • Data extraction and data analysis for hallux valgus repair 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 by assessing the differences reported between treatment arms in each study
  • A meta-analysis was not performed due to heterogeneity in study design and result reporting, restricting pooled analysis
  • The review also examined whether patients received basic analgesics defined as the prescription of any non-opioid analgesics such as paracetamol and NSAIDs or COX-2 selective inhibitors.

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 of the study and levels of evidence (LoE) 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:

  • Considerable heterogeneity between studies with regards to dosing regimens and route of administration as well as timing of pain assessments
  • The small size of many studies has the potential for estimation effect and does not provide a safety profile of the analgesic interventions
  • In a majority of the studies the analgesic intervention was not evaluated against an optimised multimodal analgesic regimen. Indeed, in many of the trials, the patients did not receive basic analgesics inclusive of paracetamol or NSAIDs
  • Pain scores were reported in many trials with unusual metrics such as summed pain intensity differences through 24 hours (SPID-24); time-weighted sum of total pain relief through 24 hours (TOTPAR-24); time-adjusted sum of pain intensity differences over 48 hours (TASPID48) or total pain relief over 8h (TOPAR8)
  • The recommendation on ankle block is based on just two studies and blocks were combined with general anesthesia

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 Hallux Valgus Repair 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)