Complex Spine Surgery 2020

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

For the complex spine surgery review, the Subgroup members were:

• Piet Waelkens¹
• Emissia Alsabbagh²
• Axel Sauter^3,4
• Girish P. Joshi⁵
• Hélène Beloeil⁶

1. Department of Anaesthesiology, KU Leuven and University Hospital Leuven, Belgium
2. CHU Rennes, Anesthesia and Intensive Care Department, Rennes, France
3. Department of Anaesthesiology and Pain Management, University of Oslo, Oslo, Norway
4. Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
5. Department of Anaesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, USA
6. University Rennes, CHU Rennes, Inserm, INRA, CIC 1414 NuMeCan, Anesthesia and Intensive Care Department, Rennes, France.

Complex spine surgery literature search

• Systematic review of the literature associated with analgesia after complex spine surgery from January 2008 to April 2020.
• The following databases were searched: the US National Library of Medicine Database (MEDLINE), the Excerpta Medica database (EMBASE), and Cochrane Databases (Search strategy).
• Included studies were RCTs or systematic reviews of analgesic, anaesthetic or surgical interventions, in English, assessing postoperative pain management for patients undergoing complex spine surgery. A study was also required to measure pain intensity using a numerical linear scoring system, such as the numerical rating scale (NRS) or visual analogue scale (VAS).
• Of 853 studies identified (800 from database searches + 53 from other sources), 111 full-text articles were reviewed in more detail.
• 31 RCTs and 4 systematic reviews met the inclusion criteria (Summary of literature selection; Included studies).
• 76 studies were excluded after full-text screening.
• The reasons for exclusion were: study type (n=25), missing outcome (n=16), no full-text (n=7), surgery type (n=3), number of vertebrae (n=2), paediatric studies (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 complex spine surgery are summarised here: Quality assessments and level of evidence assigned to included trials.

• Data extraction and data analysis for complex spine surgery adhered to the PROSPECT methodology (Joshi 2019, http://esraeurope.org/prospect-methodology)
• The systematic reviews were used to find additional studies via bibliographic screens as well as aid in formulating recommendations
• Pain intensity scores were used as the primary outcome measure
• Unless specified otherwise, it was assumed that the pain scores were assessed at rest
• In this study, we defined a 10% change as clinically important: more than 10 mm on the VAS or 1 point on the NRS
• The effectiveness of each intervention for each outcome was evaluated qualitatively by the number of studies showing a significant difference between treatment arms
• A meta-analysis was not performed due to the limited number of studies with homogeneous design and differences in how results were reported, 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.

The methodology of the PROSPECT group is unique in that it aims to synthesis clinical evidence while considering risks and benefits of interventions, as well as taking into account study design. Specifically, the group seeks to determine the relevance of study interventions in current peri-operative care practice, and critically evaluate the baseline pain treatment.

Recommendations are given when at least two congruent studies support an intervention. 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.

The proposed recommendations were sent to the PROSPECT Working Group for review and comments. A panel discussion took place, which included several rounds of individual comments followed by round-table discussions. Following a round of discussion during the face-to-face meeting, the Working Group unanimously agreed with the proposed recommendations.

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

• Considerable heterogeneity across the studies, such as the type of surgery. The number of vertebrae involved differed between studies and also differed in some populations within a single RCT
• Heterogeneity in the drug doses administered, the methods of drug administration and the sample sizes.
• Not all drugs in the RCTs were compared with a multimodal analgesic regimen.
• Lack of studies assessing analgesic interventions for different types of pain (e.g. neuropathic or radicular pain), or specific patient populations (e.g. opioid-dependent patients or those with major 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 Complex spine 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)