PROSPECT Methodology

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The PROSPECT (PROcedure-SPEcific Postoperative Pain ManagemenT) Working Group (PWG) is an international collaboration of anaesthesiologists and surgeons. The PROSPECT initiative aims to provide healthcare professionals with practical procedure-specific pain management recommendations formulated in a way that facilitates clinical decision-making across all the stages of the perioperative period. 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 analyze each study design with regards to their relevance in current perioperative care practice. The process by which the recommendations are formulated has been refined to take account not only the quality of the available procedure-specific evidence (using the protocol of the Cochrane Collaboration to evaluate randomized controlled trials (RCTs) of analgesic, anaesthetic, and surgical interventions affecting postoperative pain), but also critical expert interpretation of the study design. The refined methodology has been implemented for all procedure reviews performed from 2016 onwards.

Once the procedure to be reviewed has been identified, a subgroup is selected which consists of at least two members of the PWG; 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, assess quality and level of evidence of included studies, create data tables, carry out qualitative and quantitative analyses, critically analyze the design of the included study with regards to their relevance in current perioperative care practice, and draft 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, refines them, as necessary, and comes to a consensus agreement on all the recommendations, which are subsequently presented on the website
The process for performing a systematic review is based on the protocol of the Cochrane Collaboration. The PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines are used to perform the literature search and assess the quality and level of evidence of all included studies.
The most critical aspect of the literature search is to ensure that the appropriate “search terms” are clearly defined. The search terms are as broad as possible, to maximize the scope of the search and reduce the risk of missing relevant publications. Search terms include words or phrases related to pain and possible interventions, as well as procedure-specific terms [http://www.nlm.nih.gov/mesh/MBrowser.html]. For example, pain-related terms will include: pain OR analgesi* OR anaesthe* OR anesthe* OR vas OR "visual analog*" OR vrs OR mcgill OR epidural OR neuraxial OR intrathecal OR spinal OR caudal OR interpleural OR “peripheral nerve” OR “peripheral block” OR intercostal OR “nerve block” OR NSAID OR COX-2 OR paracetamol OR acetaminophen OR gabapentin OR pregabalin OR clonidine OR opioid OR ketamine OR corticosteroid). These terms are applied in various combinations, together with the use of the “related articles” function to maximize the search. Several electronic databases (e.g., Ovid Medline, Medline InProcess, other non-indexed citations, and Medline EPub ahead of print, Embase, and Cochrane controlled trials register published by the Cochrane Library) are utilized to identify studies published within a pre-defined time period, as determined by the PWG; secondary literature searches may also be performed and relevant systematic reviews identified in the Cochrane library.
Randomised controlled clinical trials and systematic reviews of analgesic, anaesthetic and surgical interventions, addressing pain management in the surgical procedure being reviewed are included. The RCT should report pain scores using linear pain scale, e.g. visual analogue scale (VAS) or verbal or numerical rating scale (VRS or NRS). While there is evidence that studies published in English are more likely to report beneficial effects for a particular treatment or intervention than studies published in other languages, only English language studies are included.
The selection process is performed in a step-wise process according to the PRISMA checklist. Two reviewers select the studies independently by screening the titles and/or abstracts according to a priori defined inclusion criteria (see above). The results between the two reviewers are matched. Any disagreements are resolved by consensus within the subgroup. At any stage, in the case of insoluble discrepancies, a third reviewer is involved in the discussion. Abstracts (if only titles were screened) and/or full-text of the papers included from the first step are reviewed and irrelevant papers excluded. Any disagreements are resolved by consensus. The number of excluded studies in this step and the reasons for exclusion are documented . In addition, reference lists of all relevant studies from the electronic search will be manually searched to identify additional eligible studies.
All included studies will be assessed for quality of reporting of methodology and results using the Cochrane Collaboration’s tool. Numerical scores (total 1–5) for study quality: assigned using the method proposed by Jadad 1996, to indicate whether a study reports appropriate randomisation, double-blinding and statements of possible withdrawals. Empirical research confirms that low-quality trials are associated with an increased estimate of treatment benefit compared to high-quality trials. Allocation concealment assessment: indicates whether there was adequate prevention of foreknowledge of treatment assignment by those involved in recruitment (A adequate, B unclear, C inadequate, D not used). Empirical research has shown that trials with inadequate or unclear allocation concealment report significantly greater estimates of treatment effect than those trials in which concealment was adequate. Allocation concealment was found to be more important for preventing bias than other aspects of study quality, such as generation of the allocation sequence and double-blinding. Statistical analyses and patient follow-up assessment: indicates whether statistical analyses were reported, and whether patient follow-up was greater or less than 80%. Additional study quality assessment: including an assessment of how closely the study report meets the requirements of the CONSORT statement.
The information from the included studies is extracted and tabulated, with similar interventions grouped together for ease of analyses. The information recorded includes, but is not be limited to, interventions evaluated, characteristics of study design, treatment in the control group (e.g., placebo or active comparator), patient numbers in each group, population (age, gender, opioid tolerance and psychiatric ailments), details about surgical procedure, duration of follow-up, pain scores at rest/on movement, supplementary analgesic use, time to first request for rescue analgesia, opioid-related adverse events such as postoperative nausea and vomiting, whether any other additional outcomes were assessed, Jadad score, patient follow-up >80% and appropriate statistics reported, allocation concealment, and whether  CONSORT requirements are met. In addition, a column will include the conclusions of the study in detail.
Qualitative results will be reported for all specified outcomes, and details of the assigned levels of evidence will be recorded.
Quantitative analyses will be performed if the studies are determined as suitable, according to the Prospect criteria. Data should be are homogenous and reported in an appropriate way. In addition, for the studies to be grouped together they should have uniformity in the analgesic technique(s) utilized. Studies that do not report mean and standard deviation data (for continuous variables) or proportion of patients affected (for dichotomous variables), are not included in the meta-analyses.
The information used to determine recommendation of an analgesic technique includes analyses of the systematic review. The studies that have been selected based on the Cochrane approach then undergo critical evaluation for relevance of the design with respect to the validity of the analgesic/analgesic technique in current perioperative care practice. For example, if the study design does not include an analgesic technique that would be considered as “basic” for the surgical procedure, it would not be considered optimal. Also, the subgroup will determine if the analgesic intervention would further improve postoperative pain relief and/or outcome when added to the “basic” analgesic regimen. For example, adding intravenous lidocaine infusion or TAP blocks to patients undergoing laparoscopic cholecystectomy may not be beneficial over the “basic” analgesic regimen of paracetamol + NSAIDs or COX-2 specific inhibitors + port site infiltration). Furthermore, analyses of the balance between the invasiveness of the analgesic technique and the consequences of postoperative pain as well as a balance between the analgesic efficacy and adverse event profile of the intervention is used to develop recommendations to ensure that patient safety is maintained. In addition, patient characteristics (e.g., opioid tolerance and psychiatric ailments) may be included.
All statements of evidence, including procedure-specific information, are presented to indicate whether or not they support the use of a particular intervention based on the evidence. Recommendations are presented with a brief explanation of the evidence on which they are based (including the balance of benefits and risks, where relevant). The strength of recommendations are graded based upon the agreement between the members of the subgroup. A strong recommendation will be offered when the desirable effects of an intervention clearly outweigh (intervention recommended) or clearly do not outweigh adverse effects (intervention not recommended). A weak recommendation will be offered if the overall effects are less certain—either because of low quality evidence or because evidence suggested that desirable and undesirable effects were closely balanced. The group  also develop clinical questions that need to be answered in the future. The final review document is circulated to each member of the PWG for review.
PWG members critically review the recommendations proposed by the subgroup prior to the face-to-face meeting. Individual comments on the evidence and draft recommendations are collated for presentation during the face-to-face meeting followed by round-table discussions; the Delphi method is used to achieve final consensus. The final document of consensus agreements is circulated to all PWG members for a final review and approval; any additional relevant comments are incorporated, if necessary.
A webcopy document, including a summary of the recommendations, details of the procedure-specific systematic literature review, the criteria for study inclusion as well as lists of included and excluded studies is drafted for uploading onto the website. The evidence and graded recommendations for perioperative interventions are contained within folders, in which procedure-specific evidence and recommendations are clearly separated. The web-based format offers a user-friendly way to present the large amount of information contained within each review, and encourages users to submit feedback to the PWG via the website.

Study quality assessments

Level of Evidence (LoE)

Grade of recommendation

(based on overall LoE, considering balance of clinical practice information and evidence)

Study type

Statistical analyses and patient follow-up assessment

Allocation concealment

Jadad scores

Additional assessment of overall study quality required to judge LoE

Systematic review with homogeneous results

N/A

N/A

N/A

N/A

1

A

Randomised controlled trial (RCT)

Statistics reported

and >80%

follow-up

AND

A

(15)

N/A

1

A

(based on two or more studies or a single large, well-designed study)

OR

B

(35)

N/A

OR

B

(1–2)

Yes

Randomised controlled trial (RCT)

Statistics not reported or questionable or <80% follow-up

AND/OR

B

(1–2)

Yes

2

B

(or extrapolation from one procedure-specific

LoE 1 study)

OR

C

(15)

N/A

OR

D

(15)

N/A

Non-systematic review, cohort study,

case study; (e.g. adverse effects)

N/A

N/A

3

C

Clinical practice information (expert opinion); inconsistent evidence

N/A

N/A

4

D