Evidence Review Process - ESRA
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Total Hip Arthroplasty 2019

Evidence Review Process

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

For the THA review, the Subgroup members were:

  • M. Anger1
  • T. Valovska2
  • H. Beloeil3
  • P. Lirk4
  • G.P. Joshi5
  • M. Van de Velde6
  • J. Raeder7
  1. Resident, Service d’Anesthésie Réanimation et Médecine Péri-opératoire, CHU Rennes, Université Rennes, Rennes, France
  2. Resident, Department of Anesthesiology, Henry Ford Health Systems, Wayne State School of Medicine, Detroit, Michigan, USA
  3. Professor, Service d’Anesthésie Réanimation et Médecine Péri-opératoire, CHU Rennes, Inserm Numecan, Université Rennes, Rennes, France
  4. Associate Professor, Department of Anesthesiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
  5. Professor, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, USA
  6. Professor, Department of Cardiovascular Sciences, Katholieke Universiteit Leuven and Department of Anaesthesiology, UZLeuven, Belgium
  7. Professor, Department of Anaesthesiology, Oslo University Hospital, Oslo, Norway and Division of Clinical Medicine, Medical Faculty, University of Oslo, Norway

Total hip arthroplasty literature search

  • Systematic review of the literature associated with analgesia after total hip arthroplasty between July 2010 and December 2019.
  • The following databases were searched: Embase, MEDLINE, PubMed and Cochrane Databases (Search strategy).
  • Included studies were RCTs of analgesic, anaesthetic or surgical interventions, in English, assessing postoperative pain management for adult patients undergoing total hip arthroplasty. Included studies were also required to report either pain scores (verbal or numerical) or opioid consumption.
  • Systematic reviews and meta-analyses, when available, were used to check for studies not identified in our database search.
  • Studies on acute hip fracture were excluded.
  • Of 1152 records screened, 522 full-text articles were reviewed in more detail.
  • 108 RCTs and 21 meta-analyses met the inclusion criteria (Summary of literature selection; Included studies).
  • 391 studies were excluded after full-text screening.
  • The reasons for exclusion were: pain not evaluated/no VAS score (n=241); not randomised (n=19); THA intervention cannot be individualised from other surgical procedures (n=96); hip fracture (n=19); paediatrics (n=2); chronic pain evaluated (n=12); unable to retrieve full text (n=3).

Assessments of the quality of study methodology and reporting

All included studies were assessed for quality according to PROSPECT methodology (Joshi 2019, http://esraeurope.org/prospect-methodology). The study quality assessments for total hip arthroplasty are summarised here: Quality assessments and level of evidence assigned to included trials.

  • Data extraction and data analysis for total hip arthroplasty adhered to the PROSPECT methodology (Joshi 2019, http://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 visual analogue scale or one point on a numerical rating score as clinically relevant (Myles 2017).
  • Statistically significant differences in analgesic opioid rescue medication or in opioid induced side-effects were also used as valid outcomes.
  • The efficacy of the analgesic intervention over the use of basic analgesics (paracetamol and NSAIDs or COX-2 selective inhibitors) was considered.
  • Adverse effects and clinical aspects were also evaluated.

The methodology of the PROSPECT group is unique in that it aims to critically evaluate the available literature, considering the analgesic benefit of interventions against the backdrop of basic analgesics (i.e. paracetamol and NSAIDs or COX-2-selective inhibitors) and balancing the procedure-specific efficacy and benefits of an intervention against its general risks and invasiveness.

For recommending an analgesic, at least two randomised controlled trials have to show efficacy. Recommendations were made according to PROSPECT methodology (Joshi 2019, http://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 and grades of recommendation.

A subgroup developed draft recommendations, which were then circulated amongst all the Working Group members for review and comments. A modified Delphi approach was utilised as previously described (Joshi 2019). This included obtaining feedback from PROSPECT members via e-mail, followed by revised drafts of recommendations. This was followed by face-to-face discussions with the aim of developing a consensus. For conflicting recommendations members voted via email.  The lead authors drafted the final manuscript, which was ultimately approved by the full PROSPECT group.

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

  • Many of the analgesic interventions were not evaluated against a control group that included an optimised, multimodal analgesic regimen such as paracetamol and NSAIDs or COX-2-selective inhibitors.
  • There was considerable heterogeneity between studies such as unstandardised anaesthetic techniques, variable analgesic dosing regimens, variable methods of administration, variable control groups, as well as variable time-points of pain assessments.
  • Other limiting factors include selection bias or human error by the primary reviewers.
  • Unfortunately, none of the included studies assessed patients at high risk of excessive postoperative pain (e.g. chronic opioid use, chronic pain states or significant psychiatric disorders).
  • It is possible that analgesic approaches not recommended in this review due to limited analgesic efficacy and/or concerns of adverse effects may be appropriate in situations where one or more of the primary recommendations are contraindicated or otherwise not appropriate to use.
  • Also, it may be appropriate to use additional analgesic interventions beyond the primary recommendations in patients with an anticipated higher than average risk of strong postoperative pain (e.g. chronic opioid use, chronic pain states or significant psychiatric disorders).

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 total hip arthroplasty 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)