Guideline development process

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Fertility preservation for people with cancer > Guideline development process


Introduction

These guidelines are an expanded update of the guidance for health professionals titled Fertility preservation for adolescents and young adults (AYAs) diagnosed with cancer, produced by the Clinical Oncology Society of Australia (COSA) in partnership with Canteen and the Fertility Society of Australia, as part of a national Youth Cancer Networks Program project funded by the Australian Government in 2011.

The previous guidance provided evidence-based recommendations and good practice points to assist health professionals in effectively and fully discussing with their AYA patients and their families:

  • the potential risk of cancer treatments to fertility
  • fertility preservation options for AYAs diagnosed with cancer
  • potential late effects and the need for assessment and monitoring of reproductive, sexual and endocrine health after cancer treatment ends.

The need to expand and update this guidance was identified as a priority by the Executive of the COSA AYA Group.The project was approved by COSA Council and a COSA Project Manager assigned. Cancer Council Australia was again approached to host the guidelines on the Cancer Guidelines Wiki. No external funding was received to develop these guidelines.

The updated guidelines provided evidence-based recommendations and consensus-based recommendations to assist health professionals in discussing the risks to fertility associated with cancer patients and the management of fertility preservation including:

  • the potential risk of cancer treatments to fertility
  • fertility preservation options for people diagnosed with cancer
  • supporting and managing conception and pregnancy in cancer survivors

The guidelines were developed by a multidisciplinary working group, supported by the COSA Project Manager. The guideline development process involved conducting literature searches, appraising the literature, and formulating and grading recommendations is outlined below.

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Working Group Members

COSA would like to thank all the members of the working group who contributed their expertise and time to the development of these guidelines. Membership of the working group can be found here.

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Conflict of interest register

The following working group members have declared the following conflicts of interest:

Kate White: payment for education session from Bristol Myers in 2021

Roger Hart: RJH is the medical director of Fertility Specialists of Western Australia, he has equity interests in Western IVF, and has received educational grants from MSD, Merck and Ferring Pharmaceuticals and has received honoraria from Merck. No other conflicts of interest are reported.

Kate Stern: Received prior to 2020 non-directional grants for Future Fertility Registry and Ovarian Tissue Grafting program

Robert McLachlan: Counsultancy and equity holder, Monash IVF Group

Wanda Cui: Grant funding from BCT outside submitted work. Honoraria from Janssen and AstraZeneca

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Steps in preparing clinical practice guidelines

These clinical practice guidelines are based on a systematic review of published literature. The working group developed clinical questions which determined the scope for the guidelines. The search strategy and literature search was conducted by the Project Manager in consultation with the working group. Authors were assigned to appraise the relevant literature and to formulate evidence-based recommendations where possible and consensus-based recommendations where the evidence was of insufficient quality.

The steps followed by guidelines authors are outlined below:

  1. Structure the clinical questions
  2. Develop a search strategy
  3. Search the literature
  4. Critically appraise the literature
  5. Formulate and grade recommendations

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Structure the clinical questions

The working group discussed the most important aspects of fertility for cancer patients and developed clinically focused questions.

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Develop a search strategy

Appropriate search strategies were constructed for each clinical question. MeSH terms were agreed by working group members and were expanded by the Project Manager after conducting pilot searches and searching the MeSH vocabulary. Where there was no appropriate MeSH index term available a combination of free text words were used in order to capture the relevant data.

The following exclusion criteria was applied: languages other than English. This exclusion criteria was then refined for each individual clinical question. The search strategy was approved by the members of the working group and can be found in the appendices of each page of the guidelines.

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Search the literature

Searches were completed primarily in PubMed. Search results were screened for relevance by the Project Manager. The relevant literature was collated, full-text articles obtained and sent to working group authors to include or exclude, critically appraise and use as the evidence base for their clinical question.

To view more detailed information about the literature search (such as inclusion and exclusion criteria) and the results of the search, please go to the relevant page of the guideline. The information can be found in the appendices on each page.

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Critically appraise the literature

Relevant articles selected from the literature search were reviewed by the clinical question author and each article was critically appraised with respect to level of evidence, quality of the evidence, size of the effect and clinical importance and relevance. Level of evidence was assigned according to the following criteria from the NHMRC Evidence Hierarchy:

Level Intervention Diagnosis Prognosis Aetiology Screening
I A systematic review of level II studies A systematic review of level II studies A systematic review of level II studies A systematic review of level II studies A systematic review of level II studies
II A randomised controlled trial A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among consecutive patients with a defined clinical presentation A prospective cohort study A prospective cohort study A randomised controlled trial
III-1 A pseudo-randomised controlled trial (i.e. alternate allocation or some other method) A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive patients with a defined clinical presentation All or none All or none A pseudo-randomised controlled trial (i.e. alternate allocation or some other method)
III-2 A comparative study with concurrent controls:
  • Non-randomised, experimental trial
  • Cohort study
  • Case-control study
  • Interrupted time series with a control group


A comparison with reference standard that does not meet the criteria required for Level II and III-1 evidence Analysis of prognostic factors among untreated control patients in a randomised controlled trial A retrospective cohort study A comparative study with concurrent controls:
  • Non-randomised, experimental trial
  • Cohort study
  • Case-control study


III-3 A comparative study without concurrent controls:
  • Historical control study
  • Two or more single arm study
  • Interrupted time series without a parallel control group


Diagnostic case-control study A retrospective cohort study A case-control study A comparative study without concurrent controls:
  • Historical control study
  • Two or more single arm study


IV Case series with either post-test or pre-test/post-test outcomes Study of diagnostic yield (no reference standard) Case series, or cohort study of patients at different stages of disease A cross-sectional study Case series

Source: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[1] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)

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Formulate and grade recommendations

The body of literature was assessed by each author and recommendation grades were assigned using the following criteria adapted from the NHMRC body of evidence matrix:

Component of Recommendation
Recommendation Grade
A
Excellent
B
Good
C
Satisfactory
D
Poor
Volume of evidence 1** one or more level I studies with a low risk of bias or several level II studies with a low risk of bias one or two level II studies with a low risk of bias or a systematic review/several level III studies with a low risk of bias one or two level III studies with a low risk of bias, or level I or II studies with a moderate risk of bias level IV studies, or level I to III studies/systematic reviews with a high risk of bias
Consistency 2** all studies consistent most studies consistent and inconsistency may be explained some inconsistency reflecting genuine uncertainty around clinical question evidence is inconsistent
Clinical impact very large substantial moderate slight or restricted
Generalisability population/s studied in body of evidence are the same as the target population for the guideline population/s studied in the body of evidence are similar to the target population for the guideline population/s studied in body of evidence differ to target population for guideline but it is clinically sensible to apply this evidence to target population3 population/s studied in body of evidence different to target population and hard to judge whether it is sensible to generalise to target population
Applicability directly applicable to Australian healthcare context applicable to Australian healthcare context with few caveats probably applicable to Australian healthcare context with some caveats not applicable to Australian healthcare context
1 Level of evidence determined from level of evidence criteria
2 If there is only one study, rank this component as ‘not applicable’
3 For example results in adults that are clinically sensible to apply children OR psychosocial outcomes for one cancer that may be applicable to patients with another cancer.
** For a recommendation to be graded A or B, the volume and consistency of evidence must also be graded either A or B!

Source: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[1] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)


Recommendation grades are indicated below:

Grade of recommendation
Description
A
Body of evidence can be trusted to guide practice
B
Body of evidence can be trusted to guide practice in most situations
C
Body of evidence provides some support for recommendation(s) but care should be taken in its application
D
Body of evidence is weak and recommendation must be applied with caution
PP
(practice point)
Where no good-quality evidence is available but there is consensus among guideline working group members, consensus-based guidance points are given, these are called "Practice points"

Adapted from: National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRC; 2009.[1] (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)

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Write the content

Question authors were asked to write the content for their guideline section using the following format:

  • background
  • review of the evidence
  • evidence summary with levels of evidence and numbered references
  • recommendation(s) and corresponding grade(s)
  • references

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Review of question content

The body of evidence and recommendations for each question topic were reviewed by the working group and final recommendations agreed to, based on the evidence.

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Public consultation

The draft guidelines were released for public consultation to all interested parties in Australia. The consultation process involved soliciting public review of the draft guidelines through email to COSA members, posting on the Cancer Council Australia Cancer Guidelines Wiki and alerting professional societies and other interest groups by link to the site. All feedback on the draft received during the consultation period in Australia was reviewed by the guideline working group. Subsequent changes to the draft was agreed by consensus of the guideline working group, based on consideration of the evidence.

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References

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  1. 1.0 1.1 1.2 National Health and Medical Research Council. NHMRC Australian Guidelines to reduce health risks from drinking alcohol. Commonwealth of Australia: National Health and Medical Research Council; 2009 Jan 1 Available from: http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/ds10-alcohol.pdf.