PROSPECT Methodology

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Optimal recovery after surgery depends upon effective perioperative pain management. The PROSPECT (PROcedure-SPECific postoperative pain managemenT) initiative, a collaboration of anaesthesiologists and surgeons with broad international representation, provides healthcare professionals with practical, procedure-specific pain management recommendations, formulated in a way that facilitates clinical decision-making across all stages of the perioperative period. Recommendations are based on a systematic review and critical analysis of available procedure-specific evidence. With rapid changes in perioperative care and implementation of multidisciplinary, early rehabilitation programs (fast track or enhanced recovery programs), which are becoming standard of care, the PROSPECT methodology has been modified to critically analyse the design of each study with regards to its relevance in current perioperative care practice. The process by which the recommendations are formulated has been refined to take account of not only the quality of the available procedure-specific evidence, but also critical expert interpretation of the study design. The refined methodology has been implemented for all procedure reviews performed from 2016 onwards. A detailed description of the methodology has been published and is freely accessible: Joshi et al 2019.
Once the procedure to be reviewed has been identified, a subgroup is selected which consists of at least two members of the PWG (including the subgroup lead). External members (i.e. non-PWG members) are invited to join a subgroup, if they have specific expertise in the surgical procedure to be reviewed. In addition, specialists in literature searches and/or data analysis, and research fellows may also be invited to assist with a particular project. The subgroup performs the initial literature search, and reviews all the manuscripts to identify relevant studies for inclusion, assesses the quality and level of evidence of included studies, creates data tables, carries out qualitative and quantitative analyses, critically analyses the design of the included studies with regards to their relevance in current perioperative care practice, and drafts the summary documents for presentation to the full PWG. The PWG subsequently examines, in detail, each analgesic, anaesthetic or surgical intervention recommended and not recommended by the subgroup. The PWG refines the recommendations, as necessary, and comes to a consensus agreement on all the recommendations, which are subsequently presented on the website. The processes of performing the systematic review and formulating the recommendations are outlined below. For full details, please access the PROSPECT methodology publication: Joshi et al 2019.
  • A systematic search for literature specific to perioperative pain management for the selected procedure is performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) recommendations.
  • Several electronic databases are searched, including 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).
  • Broad search terms are used to reduce the risk of missing relevant publications. Search terms include words or phrases associated with specific procedures, possible interventions and pain-related outcomes.
  • Reference lists of the relevant articles are manually screened to identify additional eligible studies that may have been missed in the initial literature search.
  • The time period for the literature search for a new review is determined by the PWG, generally the preceding 10 years; for updates the period is usually 3–5 years from the end-date of the previous review.
  • Inclusion criteria are randomised controlled clinical trials (RCTs) and systematic reviews or meta-analyses of analgesic, anaesthetic or surgical interventions, published in the English language, and addressing pain management relating to the surgical procedure being reviewed.
  • Included RCTs should report pain scores using a linear pain scale, such as the visual analogue scale or verbal or numerical rating scale.
  • Studies reporting data pooled from patients undergoing mixed surgical procedures are excluded if data tables specifically related to the surgical procedure being reviewed cannot be obtained.
  • Two reviewers independently screen the titles and abstracts.
  • Included studies then undergo full-text review and irrelevant papers are excluded.
  • At any stage, in the event of disagreement between the two reviewers, the opinion of a third reviewer is obtained.
  • A PRISMA flow chart is used to present the results of the search data, records screened, records excluded with reasons for exclusion, and studies included in the qualitative analyses.
  • The studies undergo quality assessments which are used to assign the level of evidence.
  • Criteria employed for quality assessments include:
    • Allocation concealment of treatment assignment by those involved in recruitment (A, adequate; B, unclear; C, inadequate; D, not used)
    • Quality scoring using the Jadad score (1–5) to assess randomisation, blinding, and reporting of the flow of patients
    • Participant follow-up of greater or less than 80%.
  • 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
  • Included studies are stratified by timing of the intervention (pre-operative, intra-operative or postoperative), and further categorised into the type of intervention: analgesic (systemic analgesics, analgesic adjuncts or regional analgesia techniques), anaesthetic or surgical.
  • Summary information from the included studies is extracted and tabulated using a predefined data extraction form.
  • Extracted information includes: study design (including interventions); population characteristics; outcomes assessed (e.g. pain scores, supplementary analgesic use, adverse events); and critical evaluation (e.g. relevance to current clinical practice, and use of paracetamol and non-steroidal anti-inflammatory drugs or COX-2 specific inhibitors [termed as ‘basic analgesic regimen’] in the study groups).
  • Primary outcomes are: postoperative pain intensity scores at rest and/or pain intensity during activity (when available). A change of more than 10 mm in pain scores is considered clinically relevant.
  • Secondary outcomes include: time to first request for rescue analgesia; cumulative 24-h opioid requirements; other supplementary analgesic use; opioid-related adverse events; and patient-related outcome measures.
  • The effectiveness of each intervention for each outcome is evaluated qualitatively by assessing the number of studies showing a significant difference between treatment arms (p<0.05 as reported in the study publication).
  • Meta-analyses are performed if the studies are homogenous in the analgesic technique(s) utilised, with similar outcome measures that are reported or can be estimated as mean (SD) for continuous variables and proportions for dichotomous variables.
  • 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).