Evidence Review Process - ESRA
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Haemorrhoidectomy

Evidence Review Process

PROSPECT methodology

An explanation of PROSPECT methodology and Working Group processes can be found at the following link: PROSPECT methodology primer

For the haemorrhoidectomy review, the Subgroup members were:

Dr Tarik Sammour1

Dr Ahmed W H Barazanchi2

Professor Andrew G Hill3,4 (former PROSPECT Working Group Member)

  1. Department of Surgical Oncology, MD Anderson Cancer Center, Houston, Texas, USA
  2. Department of Surgery, Palmerston North Public Hospital, Palmerston North, New Zealand
  3. Department of Surgery, South Auckland Clinical School, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand
  4. Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand

Haemorrhoidectomy literature search: review update

  • Systematic review of the literature between June 2006 and March 2016 using MEDLINE and EmBASE, following the protocol of the Cochrane Collaboration
  • Inclusion of randomized controlled trials (RCTs) in the English language assessing analgesic, anaesthetic or surgical interventions in adult excisional haemorrhoid surgery, and reporting pain on a linear visual analogue scale (VAS), verbal or numerical rating scale (Search strategy)
  • This updated review focused on excisional haemorrhoidectomy and did not review the utility of non-excisional procedures (such as stapled haemorrhoidectomy, doppler guided haemorrhoidal artery ligation)
  • Studies that reported data pooled from patients undergoing mixed surgical procedures, including haemorrhoidal surgery, were excluded
  • 464 studies were identified of which 66 were reviewed in more detail
  • 48 RCTs were included (Summary of literature selection; Included studies)
  • 18 studies were excluded after full-text screening
  • The reasons for study exclusion were: review article (8), study not RCT (2), duplicate study (6), pain scores not reported (1), no English version (1)

 

Search history

  • The first PROSPECT review included 65 studies of analgesic interventions in adult haemorrhoidal surgery, including non-excisional procedures (published 1966 to June 2006) (Joshi 2010; also see Archive on https://esraeurope.org/prospect)

All included studies were assessed for quality of reporting of methodology and results, as explained below. The study quality assessments are summarised here: Methodological quality summary and LoE

  • 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
  • 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)
  • 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

  • Summary information for each included study was recorded in data tables, including: pain scores (at rest unless otherwise specified in the study report), supplementary analgesic use, time to first analgesic request, functional outcomes and adverse effects
  • Studies were stratified according to regimen (analgesic, anaesthetic and operative), mode of delivery (systemic, neuraxial or local) and class of agent
  • The effectiveness of each intervention was evaluated qualitatively, for each outcome, by assessing the number of studies showing a significant difference between treatment arms (P < 0·05 as reported in the study publication)

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 from procedures other than excisional haemorrhoidectomy was not used in the current review, but was part of earlier PROSPECT methodology used in the last review (Joshi 2010)

Information on clinical practice was taken into account to ensure that the recommendations had clinical validity

The recommendations were formulated by the PROSPECT Working Group, using the Delphi method to collate rounds of individual comments on the evidence and draft recommendations, followed by round-table discussion, and then further Delphi rounds, to achieve final consensus

Recommendations for optimal pain relief are graded A–D according to the overall level of evidence, as determined by the quality of studies included, consistency of evidence and source of evidence: Relationship between quality and source of evidence, levels of evidence and grades of recommendation

Major limitations were the variability in the methodological quality of the randomized trials and that quantitative analyses could not be performed as a result of heterogeneity in study design and outcome measures.

The recommendations for individual techniques are based on specific interventional studies, while no firm evidence is available on combination of techniques. Further research is needed in the area of multimodal analgesia to support its use.

The AGREE II instrument (Brouwers 2010) is used internationally to assess the methodological rigour and transparency of practice guidelines. As far as possible, the methodology of the PROSPECT Haemorrhoidectomy review meets the requirements of ‘Domain 3: Rigour of development’ of the AGREE II instrument:

  • Systematic methods were used to search for evidence.
  • The criteria for selecting the evidence are clearly described.
  • The strengths and limitations of the body of evidence are clearly described.
  • The methods for formulating the recommendations are clearly described.
  • The health benefits, side effects, and risks have been considered in formulating the recommendations.
  • There is an explicit link between the recommendations and the supporting evidence.
  • The guideline has been externally reviewed by experts prior to its publication. (The evidence and recommendations are made available on the website after peer review and publication)
  • A procedure for updating the guideline is provided. (Methodology is provided so that the systematic review can be updated as required)