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:
  • Professor Girish Joshi (PROSPECT Working Group member)
  • Professor Francis Bonnet (PROSPECT Working Group member)
Dr Thomas Jaschinski (IFOM - Institut für Forschung in der Operativen Medizin, Universität Witten/Herdecke, Köln, Germany) provided support in conducting the literature search, preparing the evidence summary and coordinating the Subgroup and Working Group reviews of the evidence to prepare the final recommendations.

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


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:
  • 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
(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

 

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 >80%
follow-up

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
LoE 1 study)

C

OR

C

(1-5)

N/A

OR

D

(1-5)

N/A

Non-systematic review, cohort study,
case 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

 




Quantitative analyses

No meta-analyses were performed due to a limited number of studies of homogeneous design that reported similar outcome measures. Therefore, the procedure-specific evidence was only assessed qualitatively.
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.