Formulating the PROSPECT recommendations

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  • The subgroup determines whether each intervention should be recommended or not.
  • To be recommended, an intervention must be shown to be beneficial in at least two RCTs.
  • The subgroup assesses the relevance of each intervention to current perioperative practice.
  • Additionally, an assessment is made of whether the intervention would improve postoperative pain relief and/or outcomes when added to the ‘basic analgesic regimen’ or would be beneficial if this regimen is not possible or is contra-indicated.
  • The balance between the invasiveness of the analgesic technique and the consequences of postoperative pain, as well as the balance between the analgesic efficacy and the adverse event profile of the analgesic technique, are also considered.
  • Finally, a draft table or algorithm of the recommendations of analgesic, anaesthetic or surgical interventions is prepared, with each recommendation assigned a grade based on the overall level of evidence and balance of clinical practice information and evidence.
  • Relationship between quality and source of evidence, levels of evidence and recommendation grade:
Study type Study quality assessments Grade of recommendation
Allocation concealment (A–D) Jadad score Statistical analyses and patient follow-up Level of evidence
Systematic review with homogeneous results NA NA NA 1 A
Randomised controlled trial A or B 1–5 Statistics reported and >80% follow-up 1 A
Randomised controlled trial C or D 1–5 Statistics not reported or questionable, or <80% follow-up 2 B
Non-systematic review, cohort study, case study (e.g. some adverse effect guidance) NA NA NA 3 C
Clinical practice information (expert opinion), inconsistent evidence NA NA NA 4 D
Allocation concealment is rated as: A, adequate; B, unclear; C, inadequate; D, not used. The grade of recommendation is based on the overall level of evidence, considering the balance of clinical practice information and evidence. NA: not applicable
  • The proposed recommendations are circulated to all members of the PWG, along with data extraction files, included studies and excluded studies with reasons for exclusion, level of evidence of the included studies and reasons for recommending or not recommending interventions.
  • Five questions are asked of the Working Group about each recommendation:
  1. Is the recommended intervention clinically relevant?
  2. Does it add to the ‘basic analgesic’ technique?
  3. Does the balance between efficacy and adverse effects allow recommendation?
  4. Does the balance between invasiveness of the analgesic intervention and degree of pain after surgery allow recommendation?
  5. Are the reasons for not recommending an analgesic intervention appropriate?
  • To formulate consensus recommendations, a modified Delphi approach is used, which includes several rounds of individual comments followed by round-table discussions.
  • A final review document, including the consensus recommendations agreed during discussions at the face-to-face meeting, is circulated to the PWG for review and approval. No major changes are incorporated during this final review stage.
  • Finally, the sub-group prepares a manuscript for publication in a peer-reviewed journal, if appropriate.
  • A web copy is prepared, with the help of a medical writer, to present the large amount of evidence and the recommendations from each procedure review on the PROSPECT website in a user-friendly manner.
  • The PROSPECT website also includes the overall recommendations in several languages.
Despite the rigour of the PROSPECT methodology, there are some limitations, including:
    • The strength of the systematic review is based on the quality of published studies
    • Most RCTs assess a single-analgesic intervention with a placebo group commonly receiving opioid monotherapy and opioids as a rescue
    • There is a lack of evidence on analgesic interventions for some specific surgical procedures, and a lack of accurate dosing and duration data
    • Some interventions, doses or routes of administration in published studies are no longer appropriate in current practice
    • Some analgesic techniques are introduced into current clinical practice without being subjected to a rigorous comparative study
    • Published literature may lag behind clinical practice, thus decreasing the clinical relevance of the review
    • Most studies of analgesic interventions do not assess their effects on clinically-relevant outcomes, such as movement-related pain scores or surgery-related physical function.
  • PROSPECT is supported by an unrestricted grant from the European Society of Regional Anaesthesia and Pain Therapy (ESRA).
  • In the past, PROSPECT has received unrestricted grants from Pfizer Inc. (New York, NY, USA) and Grunenthal (Aachen, Germany).