The review of this procedure will take place in 2019 and will be published by end of 2021
Knowledge Key:
Evidence Review Process
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PROSPECT Radical Prostatectomy Subgroup and Working Group process
For each review, a Subgroup of the PROSPECT Working Group performs an initial evaluation of the evidence and also drafts clinical practice statements and recommendations, which are then discussed by the whole Working Group before a final consensus is reached.
For the Radical Prostatectomy review, the Subgroup members were:
The recommendations for postoperative pain management in Radical Prostatectomy were voted on by eight Working Group members to show the strength of consensus. The results of each vote are indicated within the PROSPECT recommendations sub-folders.
For each review, a Subgroup of the PROSPECT Working Group performs an initial evaluation of the evidence and also drafts clinical practice statements and recommendations, which are then discussed by the whole Working Group before a final consensus is reached.
For the Radical Prostatectomy review, the Subgroup members were:
- Professor Girish Joshi (PROSPECT Working Group member)
- Professor Francis Bonnet (PROSPECT Working Group member)
The recommendations for postoperative pain management in Radical Prostatectomy were voted on by eight Working Group members to show the strength of consensus. The results of each vote are indicated within the PROSPECT recommendations sub-folders.
Literature search
- Systematic review of the literature from 1966–November 2012 using MEDLINE and EmBASE, following the protocol of the Cochrane Collaboration
- Inclusion of randomised/controlled studies assessing analgesic, anesthetic or operative techniques in radical prostatectomy and reporting pain assessment, required analgesia or adverse events (Inclusion criteria for Radical Prostatectomy review, Radical Prostatectomy systematic search strategy)
- 47 studies included (Radical Prostatectomy included studies)
- 49 studies excluded after full-text screening (Radical Prostatectomy excluded studies)
- The most common reason for exclusion was that the study was not in adult patients with prostate cancer following prostatectomy using open or laparoscopic radicalprostatectomy including computer-assisted laparoscopic radical prostatectomy (CALP) (12 studies)
Radical Prostatectomy: Sources and levels of evidence (LoE) determine the grades of recommendation (GoR)
Sources of evidence in PROSPECT
The evidence for prospect is derived from three separate sources, and this evidence is taken into consideration by the prospect Working Group to determine the prospect recommendations:
Study quality assessment
For the Radical Prostatectomy review, the quality of procedure-specific evidence has been assessed according to NICE methodology, to determine the possibility of selection bias, performance bias, attrition bias and detection bias (www.nice.org.uk/media/615/64/The_guidelines_manual_2009.pdf).
Any limitations in the reporting of cited procedure-specific studies are described in the evidence tables within each Procedure-Specific Evidence folder.
GoR are assigned according to the overall LoE, which is determined by the quality of studies cited, the consistency of evidence and the source of evidence (as indicated in the Table below).
Quality indicators used to determine the LoE of individual studies:
Table: Relationship between quality and source of evidence, levels of evidence and grades of recommendation in PROSPECT
Sources of evidence in PROSPECT
The evidence for prospect is derived from three separate sources, and this evidence is taken into consideration by the prospect Working Group to determine the prospect recommendations:
- Procedure-specific evidence derived from the systematic reviews of the literature
- Transferable evidence from comparable procedures, or from other relevant sources, identified by the members of the prospect Working Group
- Current practice – A commentary on the interventions from the members of the prospect Working Group
- Practical prospect recommendations are based on all the information
Study quality assessment
For the Radical Prostatectomy review, the quality of procedure-specific evidence has been assessed according to NICE methodology, to determine the possibility of selection bias, performance bias, attrition bias and detection bias (www.nice.org.uk/media/615/64/The_guidelines_manual_2009.pdf).
Any limitations in the reporting of cited procedure-specific studies are described in the evidence tables within each Procedure-Specific Evidence folder.
GoR are assigned according to the overall LoE, which is determined by the quality of studies cited, the consistency of evidence and the source of evidence (as indicated in the Table below).
Quality indicators used to determine the LoE of individual studies:
- Allocation concealment: indicates whether there was adequate prevention of foreknowledge of treatment assignment by those involved in recruitment (in the table below, 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 (Chalmers 1983, Schulz 1995, Moher 1998). 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 (Chalmers 1983, Schulz 1995, Moher 1998, HigginsandGreen 2005: Section 6.3. http://www.cochrane.org/resources/handbook/hbook.htm)
- Statistical analyses and patient follow-up: indicates whether statistical analyses were reported, and whether patient follow-up was greater or less than 80%.
- 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 found that low-quality trials were associated with an increased estimate of treatment benefit than high-quality trials (Moher 1998)
Table: Relationship between quality and source of evidence, levels of evidence and grades of recommendation in PROSPECT
|
Study quality assessments |
Level of Evidence (LoE) |
Grade of recommendation |
|||||
Study type |
Statistical analyses and patient follow-up assessment |
|
Allocation concealment |
Jadad scores |
Additional assessment of overall study quality required to judge LoE |
|
Procedure-specific |
Transferable |
|
Systematic review with homogeneous results |
N/A |
|
N/A |
N/A |
N/A |
1 |
A |
B |
|
Randomised controlled trial (RCT) |
Statistics reported |
AND |
A |
(1-5) |
N/A |
1 |
A (based on two or more studies or a single large, well-designed study) |
B |
|
OR |
||||||||
|
B |
(3-5) |
N/A |
||||||
|
OR |
||||||||
|
B |
(1-2) |
Yes |
||||||
|
RCT |
Statistics not reported or questionable or <80% follow-up |
AND/OR |
B |
(1-2) |
Yes |
2 |
B (or extrapolation from one
procedure-specific |
C |
|
OR |
||||||||
|
C |
(1-5) |
N/A |
||||||
|
OR |
||||||||
|
D |
(1-5) |
N/A |
||||||
|
Non-systematic review, cohort study,
(e.g. some adverse effects evidence) |
N/A |
|
N/A |
3 |
C |
|||
|
Clinical practice information (expert opinion); inconsistent evidence |
N/A |
|
N/A |
4 |
D
|
|||
Transferable evidence
Transferable evidence has been included to support the procedure-specific evidence where this is insufficient to formulate the recommendations.
Transferable evidence includes evidence of analgesic efficacy from a variety of procedures that have some similarity to radical prostatectomy in terms of pain pathology, including abdominal surgery, laparoscopic colonic resection, laparoscopic cholecystectomy, open or laparoscopic hysterectomy, herniorraphy, percutaneous nephrolithotomy surgery and urologic surgery. Systematic reviews of pain management for multiple surgical procedures are also cited.
Transferable evidence of other outcomes, such as adverse effects, is included from a variety of surgical procedures.
Transferable evidence has been included to support the procedure-specific evidence where this is insufficient to formulate the recommendations.
Transferable evidence includes evidence of analgesic efficacy from a variety of procedures that have some similarity to radical prostatectomy in terms of pain pathology, including abdominal surgery, laparoscopic colonic resection, laparoscopic cholecystectomy, open or laparoscopic hysterectomy, herniorraphy, percutaneous nephrolithotomy surgery and urologic surgery. Systematic reviews of pain management for multiple surgical procedures are also cited.
Transferable evidence of other outcomes, such as adverse effects, is included from a variety of surgical procedures.