Evidence Review Process - ESRA
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Rotator Cuff 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 rotator cuff repair surgery review, the Subgroup members were:

Octavian Toma1,2

Barbara Persoons3

Esther Pogatzki-Zahn4

Marc Van de Velde5

Girish P. Joshi6

  1. Spitalfacharzt, Institute for Anesthesiology, Spital STS AG Thun, Switzerland
  2. Postgraduate Student MSc Regional Anaesthesia, University of East Anglia, Norwich, UK
  3. Resident, Department of Cardiovascular Sciences, Section Anesthesiology, KU Leuven and University Hospital Leuven, Belgium
  4. Professor, Department of Anesthesiology, Intensive Care, and Pain Medicine, University Hospital Münster, Germany
  5. Professor, Department of Cardiovascular Sciences, Section Anesthesiology, KU Leuven and University Hospital Leuven, Belgium
  6. Professor, Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas, Texas, US

Rotator cuff repair surgery literature search

  • Systematic review of the literature associated with analgesia after rotator cuff repair surgery from 1 January 2006 to 15 April 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 rotator cuff repair using analgesic, anaesthetic or surgical interventions
  • 3069 studies were identified of which 322 were reviewed in more detail
  • 59 RCTs and one systematic review were included (Summary of literature selection; Included studies)
  • 262 studies were excluded after full-text screening
  • The reasons for study exclusion were: editorials/comments (3), not specific to rotator cuff repair (120), no pain scores (47), methodological reviews (11), no control group (9), no short term follow up (69), withdrawn articles (3)

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 rotator cuff repair surgery are summarised here: Quality assessments and level of evidence.

  • Data extraction and data analysis for rotator cuff 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 qualitatively by assessing the number of studies showing a significant difference between treatment arms (p<0.05 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 for rotator cuff repair surgery 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:

  • Heterogeneity between studies, such as variable dosing regimens, methods of administration and control groups as well as inconsistency in the time-points of pain assessments
  • Small sample sizes. Many of the included studies might not have been adequate to draw valid conclusions concerning the safety profile of analgesic interventions
  • Lack of evaluation of interventions against a control group that included an optimised multimodal analgesic regimen such as paracetamol and NSAIDs.

Future adequately powered studies should assess the effects of analgesic interventions not only on time to ambulation and length of hospital stay but also other patient-related outcome measures such as chronic pain and long-term opioid consumption.

 

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 Rotator Cuff 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)