Appendix B. Guideline development process

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Introduction

The Australian Government Department of Health strategy for reviewing the policy and operation of the National Cervical Screening Program (NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears.) began in November 2011. In April 2014, the Medical Service Advisory Committee (MSACThe Australian Medical Services Advisory Committee)[1][2] recommended that a 5-yearly primary human papillomavirus (HPVHuman papillomavirus) test for women aged 25–69 years, including partial genotyping for HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory. and an exit test between 70 and 74 years of age, should replace the current 2-yearly Pap test for women aged 18–69 years.Some aspects of the management pathway were specified by MSACThe Australian Medical Services Advisory Committee, including that:

  • women with a positive oncogenic for HPV (16/18) test result should be referred for colposcopy
  • reflex liquid-based cytology (LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory.) would be performed on all women with a positive oncogenic HPV (any type)Women with a positive HPV test result of any oncogenic HPV types detected using routine HPV testing in a pathology laboratory. test result:
  • to inform colposcopy, in the case of a positive oncogenic HPV (16/18)Women with a positive HPV test result of HPV types 16 and/or 18 detected using routine HPV testing in a pathology laboratory. test result
  • for triage, in the case of a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result.
  • women with a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result and triage LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. prediction of possible high-grade squamous intraepithelial lesion (pHSILPossible HSIL in the Australian Modified Bethesda System is broadly equivalent to ASC-H in US Bethesda system.) or a high-grade squamous intraepithelial lesion (HSILHigh-grade squamous intraepithelial lesionIn the Australian context, HSIL is used to refer to a cytology predictive of a high grade precancerous lesion (AMBS 2004), or histologically confirmed high grade precancerous lesion (HSIL-CIN2 or HSIL-CIN3 as per LAST terminology).) would be referred for colopscopy.

Subsequent to the MSACThe Australian Medical Services Advisory Committee recommendations, new clinical management guidelines were needed in Australia to:

  • support the proposed renewed clinical pathway
  • provide guidance for clinicians regarding the follow up of women with a positive screening result
  • inform national cervical screening policies and operations
  • inform the development of a National Cancer Screening RegisterA database of identifiable persons containing defined demographic and health information, established for a specific purpose. In the case of cervical screening or other cancer screening registers, the purpose includes inviting eligible persons for screening, sending reminders when they are overdue for screening, follow up of abnormalities, statistical reporting and research.
  • develop health professional and consumer communications and resources.

The Department of Health commissioned Cancer Council Australia to develop the clinical management guidelines for the prevention of cervical cancer. The project formally commenced in June 2015, funded by the Department of Health.

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Guideline development group and guideline scope

Professor Ian Hammond and Associate Professor Marion Saville, who were members of the National Cervical Screening Program Renewal Steering Committee, were appointed as chairs of this guideline project. A multi-disciplinary working party (Cancer Council Australia Cervical Cancer Screening Guidelines Working Party) was established, involving representatives from all relevant specialities and disciplines involved in the diagnosis and management of cervical cancer, including consumer representatives.

Declarations of interests were collated from all nominated individuals and evaluated prior to the first working party meeting. Management of competing interests describes the process and provides the complete Conflict of interest register, including evaluation outcomes. All working party members were advised to forward any further updates to their declarations of interest, in line with the Code of practice for dealing with conflict of interests.[3] Any updates were forwarded for evaluation and the register updated accordingly.

A project team based at Cancer Council Australia was responsible for project governance and management. A technical project team based at Cancer Council NSW conducted the systematic reviews, literature reviews and modelling required for this project. The technical team was also responsible for liaising with the working party members in regards to content development, content drafting and compiling the Appendix D. Technical report.

The clinical practice guidelines were developed according to the procedures and requirements for meeting the 2011 NHMRCNational Health and Medical Research Council standard for clinical practice guidelines.[4] The development program was designed to meet the scientific rigour required by the standard for developing high-quality, evidence-based clinical practice guidelines. A series of NHMRCNational Health and Medical Research Council resources and handbooks[5][6][7][8][9][10][11][12][13] guided the process and outlined the major steps and expectations involved in developing guidelines. These documents provided the definitions and protocols for developing research questions and search strategies, conducting systematic literature reviews, summarising and assessing the relevant literature and finally, formulating and grading the recommendations. They also included checklists and templates created to satisfy designated standards of quality and process.

At an initial teleconference meeting, the working party confirmed the scope of the guidelines and the clinical questions to be included. The aim was to revise the 2005 NSCP guideline Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities.[14] The clinical questions addressed areas of uncertainty and clinical scenarios that required reconsideration as a result of the renewed NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears.. For completeness, MSACThe Australian Medical Services Advisory Committee recommendations and relevant NHMRCNational Health and Medical Research Council-approved 2005 recommendations [14] considered to be unaffected by the renewed National Cervical Screening Program were included. The method by which each recommendation was developed is identified in the guidelines (see Assessing the body of evidence and formulating recommendations).

The included clinical questions, as well as additional topics such as cervical cancer epidemiology and terminology, were allocated to specific working party members to act as lead author teams according to their areas of expertise.

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Steps in preparing clinical practice guidelines to NHMRCNational Health and Medical Research Council criteria

The evidence underpinning the recommendations has been synthesised from systematic reviews of the literature and generated from modelling analyses for those aspects of clinical management involved in the pathway to colposcopy that constitute major changes to the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears.. During the first working Party meeting it was agreed that certain 2005 NHMRCNational Health and Medical Research Council-approved guidelines sections remained valid, whereas others required review. For those requiring review, systematic reviews were undertaken to identify relevant evidence where new recommendations were anticipated, and general literature reviews were conducted when no significant changes were considered likely and it was anticipated that only additional practice points might be required. Based on the available evidence, the 2005 NHMRCNational Health and Medical Research Council-approved guidelines[14] have been combined with current revisions in this document to provide comprehensive recommendations for management.

For every clinical question the below steps were followed:

1. A structured clinical question in PICO format (population, intervention, comparator, outcomes) was developed by the working party.
2. For each question, a systematic or general literature review was undertaken as outlined in Figure B.1.
Systematic reviews were undertaken for most questions, as the aim was to develop evidence-based recommendations if the evidence permitted. As the systematic reviews were addressing questions concerned with the management flow-on effects of new screening tests, it was anticipated that there may be limited, if any evidence, available directly addressing many of the questions.

The working party determined, a priori, that in the event that a systematic review found no evidence directly addressing a PICO question, a general literature review was to be undertaken to inform the drafting of consensus-based recommendations, with the exception of three questions. For these three questions it was planned that the systematic reviews would be extended to include evidence that indirectly addressed the question and that modelling analyses would also be used to provide evidence for two of these questions.

For two questions clinical questions the working party did not anticipate that the NHMRCNational Health and Medical Research Council approved 2005 recommendations would be significantly impacted by the renewed National Cervical Screening Program and as a result determined a priori that only general reviews were to be undertaken to inform the drafting of additional practice points .

Figure B.1. Review process

Review process

3. All systematic reviews and modelling analyses were documented in a Technical report and the results of each general review were summarised in a review summary.
4. Where available, the body of evidence for each systematic review and/or modelling analysis were assessed and recommendations and practice points formulated following the NHMRCNational Health and Medical Research Council process and recommendation categories.
Where no evidence was found directly addressing a clinical question, a general review of the literature was considered when drafting consensus-based recommendations or practice points.
Where a systematic review was not undertaken a general review of the literature was considered when drafting practice points.
Adapted MSACThe Australian Medical Services Advisory Committee recommendations and consensus-based recommendations based on the 2005 NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. guidelines are clearly identified.
5. Content narrative was developed based on the findings of the reviews.

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Developing a structured clinical question

All proposed questions were reviewed on the basis of their purpose, scope and clinical importance to the target audience and those requiring systematic reviews were structured according to the PICO (populations, interventions, comparisons, outcomes) framework (see Appendix C. Clinical question list).

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Systematic reviews and modelling analyses

Each question that was addressed by a systematic review and/or modelling analyses is accompanied by a detailed Technical report.

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Search for existing relevant guidelines and systematic reviews

Relevant recent (2005 onwards) guidelines were identified by scanning the citations identified by the literature search, searching the National Guideline Clearinghouse and the Guidelines Resource Centre and, in the case of guidelines for screening immune-deficient women, consulting experts in that field.

To be considered for adoption, guidelines had to be directly relevant, based on systematic reviews of the evidence and meet the pre-specified criteria of scores of greater or equal to 70% for the domains rigour of development, clarity of presentation and editorial independence of the AGREE II instrument.

No existing clinical practice guidelines suitable for adoption were identified.

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Developing a search strategy for systematic reviews

For each PICO question, literature search strategies were developed and conducted by the technical team. Most searches included terms for HPV and were limited or widened as necessary according to the PICO question. Search strategies were designed to maximise sensitivity and used both text terms and subject headings for each included electronic database. The following electronic databases were searched for articles published from 2004 until 31st August 2015:

  • Medline – bibliographic references and abstracts to articles in a range of languages on topics such as clinical medical information and biomedicine, and including the allied health fields, biological and physical sciences
  • EMBASE – major pharmacological and biomedical database indexing drug information from 4550 journals published in 70 countries
  • Cochrane Central RegisterA database of identifiable persons containing defined demographic and health information, established for a specific purpose. In the case of cervical screening or other cancer screening registers, the purpose includes inviting eligible persons for screening, sending reminders when they are overdue for screening, follow up of abnormalities, statistical reporting and research. of Controlled Trials (CENTRAL) – contains references to controlled trials in health care
  • Database of Abstracts of Reviews of Effects – contains details of systematic reviews that evaluate the effects of healthcare interventions and the delivery and organisation of health services
  • Health Technology Assessment – details on ongoing and completed health technology assessments (studies of the medical, social, ethical, and economic implications of healthcare interventions).
  • The Cochrane Database of Systematic Reviews – contains systematic reviews of primary research in human health care and health policy, and are internationally recognised as the highest standard in evidence-based health care.

A search filter to retrieve relevant literature considering Aboriginal and Torres Strait Islander peoples was added to each question.

The reference lists of all identified articles were checked for additional potentially relevant articles. The systematic literature search strategies for each PICO question are documented in the Technical report for of each question (see Appendix D. Technical report).

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Screening of literature results for systematic reviews

All retrieved literature results were screened against pre-specified inclusion and exclusion criteria specific for each question (see Appendix D. Technical report) in two stages:

a) First screen: the titles and abstracts of all retrieved literature were screened and only potentially relevant citations were retained.

b) Second screen: the full text of each remaining citation was assessed against the pre-specified inclusion and exclusion criteria for that question. Articles that met the inclusion criteria were included in the systematic review. The retrieved articles that were not included and the reason for their exclusion were documented and are included in the technical reports (see Appendix D. Technical report).

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Critical appraisal and data extraction of each included article in systematic reviews

For each included study, two assessors independently assessed the risk of bias using a study design specific assessment tool and where necessary pre-specified criteria. Any disagreements were adjudicated by a third reviewer.

The characteristics of the study and the relevant data was extracted and summarised in study characteristics and results tables. Each data extraction was checked by a second assessor.

These tables are included in Appendix D. Technical report).

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Summary of the relevant evidence in systematic reviews

For each outcome examined, the results, level of the evidence according to NHMRCNational Health and Medical Research Council levels (Table B.1), the risk of bias due to study design, and the relevance of the evidence for each included study were documented in a body of evidence table in the Technical report for that question.

Table B.1. Designations of levels of evidence according to type of research question (NHMRCNational Health and Medical Research Council, 2009)

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 amongst 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. NHMRCNational Health and Medical Research Council additional levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRCNational Health and Medical Research Council; 2009. (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)

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Modelling analyses

Modelling analyses were planned a priori to address two of the clinical questions which related to the management of women in whom HPV types 16 and/or 18 are not detected, but with a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result. Clinical tests that allow partial genotyping for HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory. are comparatively new, and the overwhelming majority of trials of HPV-based screening used earlier clinical tests which did not specifically identify whether or not HPV types 16 and/or 18 were identified.

One clinical trial (ATHENA)[15] compared cytology-based screening with a clinical HPV test which that provided partial genotyping, but however it did not randomise women with a positive oncogenic for non-16/18 HPV types (not 16/18) test result to different kinds of management. A second clinical trial (Compass) was underway in Australia at the time this guideline was commissioned[16]; while directly relevant, longitudinal data were not yet available from this trial to address these clinical questions. Therefore, it was thought very likely that the systematic review would not identify any studies that could directly answer the question of how to manage women with a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result.

It was also considered a priori that management of these women could not be informed by trials that reported outcomes in women with a positive oncogenic HPV (any type)Women with a positive HPV test result of any oncogenic HPV types detected using routine HPV testing in a pathology laboratory. test result, because their underlying risk would certainly be higher than, and not comparable to, the risk in women in whom HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory. was not detected but with a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result. This consideration was made because the risk associated with HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory. is known to be far greater than that for other HPV types, and HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory. also generally make up a high proportion of infections among women with a positive oncogenic HPV (any type)Women with a positive HPV test result of any oncogenic HPV types detected using routine HPV testing in a pathology laboratory. test result, and thus would strongly influence the overall risk in that group.

Modelled analyses were undertaken using a simulation model that had previously been used in the effectiveness and economic evaluation of the proposed changes to the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. performed for MSACThe Australian Medical Services Advisory Committee.[17] As part of the evaluation for MSACThe Australian Medical Services Advisory Committee, this model had been customised to include detailed modelling of both the pre-renewal NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. in Australia, and of the proposed changes. It included detailed local data on screening behaviour, screening test performance calibrated to fit observed Australian pathology data, and detailed clinical management pathways informed by an expert advisory group, the Renewal Steering Committee (RSC). Model predictions for age-specific endpoints, such as cervical cancer incidence and mortality, and rates of screen-detected abnormalities, were consistent with observed Australian data. The detailed model of cervical cancer screening, diagnosis and cancer treatment and survival in Australia was overlaid on a natural history model which had been developed over the course of a decade. The natural history model had been validated to observed data in many settings when an appropriate setting-specific screening models were overlaid. The model also has a dynamic HPV transmission component, which allowed the impact of the National HPV Vaccination Program (NHVP) to be taken into account, including both direct and indirect effects (herd protection). The HPV transmission model has also been validated against observed reductions in HPV infections since the inception of the NHVP.[18] All model assumptions had been previously reviewed by the RSC, the Economic Subcommittee of MSACThe Australian Medical Services Advisory Committee and MSACThe Australian Medical Services Advisory Committee itself.

There are no NHMRCNational Health and Medical Research Council levels of evidence for modelling studies.

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Assessing the body of evidence and formulating recommendations

The working party participated in a face-to-face meeting at which the technical team presented the preliminary findings of the systematic reviews, general literature searches, and modelling analyses.

For clinical questions for which there was evidence from systematic reviews, the author teams, in collaboration with the technical team, assessed the volume of the evidence, its consistency, clinical impact, generalisability and applicability, and developed evidence statements (see Appendix D. Technical report) as documented in the NHMRCNational Health and Medical Research Council Evidence Statement. This process is described in NHMRCNational Health and Medical Research Council’s Additional levels of evidence and grades for recommendations for developers of guidelines (2009).[19]

Following grading of the evidence and development of evidence statements, expert authors formulated evidence-based recommendations and determined a grade (Table B.2, Table B.3).

Where a systematic review yielded insufficient evidence on which to base an evidence-based recommendation, the expert authors drafted consensus-based recommendations (Table B.4). Practice points, on topics outside the scope of the clinical questions, were developed to support recommendations, as necessary.

This guideline also includes recommendations developed outside the wording group process (Table B.5):

  • evidence-based recommendations by MSACThe Australian Medical Services Advisory Committee, based on systematic reviews undertaken during the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. renewal process,[1][2] labelled as MSACThe Australian Medical Services Advisory Committee evidence-based recommendations
  • recommendations determined by NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. policy[20]
  • consensus-based recommendations modified from pre-renewal NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. guidelines (2005).[14]

    Table B.2. Grading of recommendations

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. NHMRCNational Health and Medical Research Council additional levels of evidence and grades for recommendations for developers of guidelines. Canberra: NHMRCNational Health and Medical Research Council; 2009. (https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf)

Table B.3. Overall recommendation grades

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

Table B.4. NHMRCNational Health and Medical Research Council approved recommendation types and definitions

Type of recommendation
Definition
Evidence-based recommendation
A recommendation formulated after a systematic review of the evidence, indicating supporting references
Consensus-based recommendation
A recommendation formulated in the absence of quality evidence, after a systematic review of the evidence was conducted and failed to identify admissible evidence on the clinical question
Practice point
A recommendation on a subject that is outside the scope of the search strategy for the systematic review, based on expert opinion and formulated by a consensus process
Source: National Health and Medical Research Council. Procedures and requirements for meeting the NHMRCNational Health and Medical Research Council standard for clinical practice guidelines. Melbourne: National Health and Medical Research Council, 2011

Table B.5. Key to types of recommendations in these guidelines

Type Source Description#
Evidence-based recommendation Developed for this guideline Recommendations formulated by the guideline development group based on a systematic review of quality evidence and graded according to an NHMRCNational Health and Medical Research Council-approved method
MSACThe Australian Medical Services Advisory Committee evidence-based recommendation Developed by MSACThe Australian Medical Services Advisory Committee from MSACThe Australian Medical Services Advisory Committee-commissioned evaluation Evidence-based recommendation from MSACThe Australian Medical Services Advisory Committee review
Policy recommendation Determined by NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. policy Recommendations based on NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. policy
Consensus-based recommendation Developed for this guideline Recommendations formulated by the guideline development group, using a using a consensus-reaching process, when a systematic review was undertaken and insufficient quality evidence was found on which to base a recommendation
Consensus-based recommendation Adopted/modified from pre-renewal NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. guidelines Recommendations based on 2005 NHMRCNational Health and Medical Research Council-approved guidelines formulated by the guideline development group, using a consensus-reaching process
#When viewed online, the description for each recommendation appears when the reader places the cursor over the question mark symbol in the recommendation heading.

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General literature reviews

General reviews were undertaken to support the drafting of:

  • consensus-based recommendations in the absence of evidence directly addressing the PICO question
  • practice points.

The general reviews are documented in review summaries. The review summary for each question contains a summary of:

  • potentially relevant guidelines, including the relevant 2005 NHMRCNational Health and Medical Research Council-approved guidelines.
  • literature searches– undertaken using the Medline and Embase databases and designed to maximise specificity
  • key characteristics and results of the most relevant studies identified.

The technical team presented their preliminary findings at a face-to-face meeting of the working party. Consensus-based recommendations and practice points were drafted by the lead authors, based on a consideration of any relevant evidence and expert opinion. These were then presented to the working party for consideration.

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Writing the content

Guideline chapters were drafted using the following format:

  • general introduction to the clinical question
  • background to the clinical question, including its clinical importance and historical evidence, where relevant
  • review of the evidence including, for systematic review evidence, the number, quality and findings of studies identified by the systematic review
  • evidence statements for systematic reviews and modelling analyses in tabular form including levels of evidence and references for studies included in the systematic review,
  • evidence-based recommendation(s) and corresponding grade(s), consensus-based recommendations and practice points
  • implications for implementation of the recommendations where applicable, including possible effects on usual care, organisation of care, and any resource implications
  • discussion, including unresolved issues, relevant studies currently underway, and future research priorities
  • references.

The content draft was then reviewed by all working party members. The draft documents underwent several iterations until agreement on these drafts was reached.

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Review of the draft chapters

All draft chapters were circulated to the working party. The whole group was asked to review the content and submit feedback. Members were asked to submit further suggestions on consensus-based recommendations and practice points.

A face-to-face meeting with all working party members was held to review and finalise the draft guidelines for public consultation. Prior to this meeting, the latest iteration draft guidelines were circulated via the wiki. All working party members were asked to review the content, individual recommendations and practice points in detail, and to identify and note any controversies and points to be discussed at the group meeting.

During the meeting, each recommendation and practice point was tabled as an agenda item. Each was reviewed and approved by consensus, which was reached by voting. The working party Chairperson nominated a particular recommendation/practice point to be reviewed and the panellists had the opportunity to discuss any issues and suggest revisions to recommendations and practice points. Each recommendation and practice point was approved once consensus was reached by the eligible panellists (excluding representatives of the funding bodies and any panellists who could not participate due to conflict of interest).

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Public consultation

A complete draft of the guideline was sent out for public consultation from 15 February to 15 March 2016. Submissions were invited from the general public, professional societies and groups, and other relevant stakeholders. Relevant professional societies and groups, consumer groups and other relevant stakeholders were contacted.

All feedback on the draft received during the consultation period in Australia was compiled and sent to the relevant author team to review their draft content, assessing and considering the submitted comments. Each additional paper submitted during public consultation was assessed by the methodologist team against the review protocol.

All public consultation comments and suggested amendments were considered at a face-to-face meeting of the working party on 1 April 2016. Subsequent changes to the draft were agreed by consensus, based on consideration of the evidence and, in the absence of evidence, expert opinion. The consensus process was similar to that followed during earlier face-to-face working party meetings.

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Organisations endorsing the guidelines

The following medical colleges and professional bodies endorse these guideline:

  • The Royal Australian College of General Practitioners (RACGP)
  • The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOGThe Royal Australian and New Zealand College of Obstetricians and Gynaecologists)
  • The Royal College of Pathologists of Australasia (RCPARoyal College of Pathologists of Australasia)
  • Australian Society for ColposcopyThe examination of the cervix and vagina with a magnifying instrument called a colposcope, to check for abnormalities. and Cervical Pathology (ASCCPAustralian Society for Colposcopy and Cervical Pathology)
  • Australian Society of Gynaecologic Oncologists (ASGO).

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Dissemination and implementation

A multi-strategy approach will be followed for the dissemination and implementation of the guideline, as this has shown to positively influence guideline uptake.[21][22]

This will include a campaign to raise awareness of the new guidelines that incorporates organised media coverage through multiple outlets. The guidelines will be distributed directly to relevant professional and other interested groups and through meetings, national and international conferences, and other professional development and continuing medical education (CME) events. Local expert leaders will be identified and approached to facilitate dissemination and act as champions for the guidelines.

A significant effort will be made to have the guidelines introduced to senior undergraduate medical students and to encourage the relevant learned colleges to support the guidelines and to foster their integration into hospital and community practice through resident and registrar education activities.

The guidelines will be made available as an online guideline via the Cancer Council Australia Cancer Guidelines Wiki. The online guideline version increases availability as well as accessibility, and usage will be tracked and analysed with a web analytics solution. Interlinking and listing the guidelines on national and international guideline portal is an important part of the digital dissemination strategy. Important Australian health websites, such as EviQ and healthdirect Australia will be approached to link to the online guideline. The guideline will also to be listed on national and international guideline portals such as Australia’s Clinical Practice Guidelines Portal, Guidelines International Network guidelines library and National Guidelines Clearinghouse. The Cancer Guidelines Wiki is a responsive website that is optimised for mobile and desktop access.

As part of the online guideline, an online learning module will be developed to reinforce the guidelines content knowledge for participants, thus support guideline implementation and uptake.

The Cancer Guidelines Wiki is based on semantic web technology, so the guidelines are available in a machine-readable format, which offers the possibility to easily integrate the guideline content with systems and web applications used in the Australian healthcare context. Use of the guidelines as part of core curriculum in specialty exams will be encouraged.

As the guidelines form part of the renewed National Cervical Screening Program, additional promotion and awareness of the guidelines will be incorporated into the overarching program communication activities for health professionals, pathologists and consumers in the lead up to 1 December 2017 and post implementation.

It is recognised that a planned approach is necessary to overcome specific barriers to implementation in particular settings and to identify appropriate incentives to encourage uptake of guideline recommendations. Implementation of the guidelines will require a combination of effective strategies and may include further CME initiatives and interactive learning, the development and promotion of computer-assisted decision aids and electronic decision-support systems, and the creation of audit and other clinical tools.

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Future updates

The incoming literature updates will continue to be monitored for each review question. If there is strong evidence emerging in a specific area, even if not considered previously, the Cancer Council Australia Cervical Cancer Screening Guidelines Working Party will be reconvened to assess if this evidence warrants further systematic review(s) and updating of recommendations.

It is recommended that these guidelines should be updated within 5 years.

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Project funding

The development of this guideline was funded through a grant by the Department of Health. The views of the funding body have not influenced the content of the guideline.

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References

  1. 1.01.1 Medical Services Advisory Committee. National Cervical Screening Program renewal: effectiveness modelling and economic evaluation in the Australian setting. Report November 2013. MSAC application 1276. Canberra: Australian Government Department of Health; 2014 Available from: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/E6A211A6FFC29E2CCA257CED007FB678/$File/Renewal%20Economic%20Evaluation.pdf.
  2. 2.02.1 Medical Services Advisory Committee. MSAC Outcomes. Application No. 1276 – Renewal of the National Cervical Screening Program. [homepage on the internet] Canberra: Australian Government Department of Health; 2014 [updated 2015 Apr]. Available from: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/FD36D6990FFAA639CA25799200058940/$File/1276%20-%20Final%20MSAC%20PSD%20-%20NCSP%20Renewal.pdf.
  3. Cancer Council Australia. A Code of Practice for Declaring and Dealing with Conflicts of Interest. Sydney: Cancer Council Australia; 2015.
  4. National Health and Medical Research Council. Procedures and requirements for meeting the NHMRC standard for clinical practice guidelines. Melbourne; 2011.
  5. National Health and Medical Research Council. A guide to the development, evaluation and implementation of clinical practice guidelines. Commonwealth of Australia: National Health and Medical Research Council; 1999 Jan 1 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp30.pdf.
  6. National Health and Medical Research Council. How to review the evidence: Systematic identification and review of scientific literature. Canberra: National Health and Medical Research Council; 1999 Available from: http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp65.pdf.
  7. National Health and Medical Research Council. How to present evidence for consumers: Preparation of consumer publications. Canberra: Commonwealth of Australia; 1999.
  8. National Health and Medical Research Council. How to prepare and present evidence-based information for consumers of health services: A literature review. Commonwealth of Australia: National Health and Medical Research Council; 1999 Jan 1 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp72.pdf.
  9. National Health and Medical Research Council. How to put evidence into practice: Implementation and dissemination strategies. Commonwealth of Australia: National Health and Medical Research Council; 2000 Jan 1 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp71.pdf.
  10. National Health and Medical Research Council. How to use the evidence: assessment and application of scientific evidence. Commonwealth of Australia: National Health and Medical Research Council; 2000 Jan 1 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp69.pdf.
  11. National Health and Medical Research Council. How to compare the costs and benefits: evaluation of the economic evidence. Commonwealth of Australia: National Health and Medical Research Council; 2001 Jan 1 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp73.pdf.
  12. National Health and Medical Research Council. Using socioeconomic evidence in clinical practice guidelines. NHMRCNational Health and Medical Research Council 2002 Abstract available at http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp89.pdf.
  13. National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for guideline developers. Canberra: National Health and Medical Research Council; 2009 Available from: https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf.
  14. 14.014.114.214.3 National Health and Medical Research Council. Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities. Canberra: NHMRCNational Health and Medical Research Council; 2005.
  15. Wright TC Jr, Stoler MH, Behrens CM, Apple R, Derion T, Wright TL. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol 2012 Jan;206(1):46.e1-46.e11 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/21944226.
  16. Saville M, Canfell K, Castle P, Gebski V, Caruana M, Brotherton J, et al. Compass Trial, unpublished data (www.compasstrial.org.au).; 2015.
  17. Lew JB, Simms K, Smith M, et al. National Cervical Screening Program renewal: effectiveness modelling and economic evaluation in the Australian setting (Assessment report).MSAC Application No. 1276. Canberra: MSACThe Australian Medical Services Advisory Committee; 2014.
  18. Smith MA, Canfell K. Testing previous model predictions against new data on human papillomavirus vaccination program outcomes. BMC Res Notes 2014 Feb 25;7:109 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24568634.
  19. National Health and Medical Research Council. NHMRC levels of evidence and grades for recommendations for guideline developers. Canberra: National Health and Medical Research Council; 2009 Available from: https://www.nhmrc.gov.au/_files_nhmrc/file/guidelines/developers/nhmrc_levels_grades_evidence_120423.pdf.
  20. Standing Committee on Screening. National Cervical Screening Policy March 2016.; 2016 Available from: http://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Prevention/Draft_NCSP_Policy.
  21. National Institute of Clinical Studies. Do guidelines make a difference to health outcomes?; 2006 Available from: https://www.nhmrc.gov.au/_files_nhmrc/file/nics/material_resources/Do%20guidelines%20make%20a%20difference%20to%20health%20care%20outcomes.pdf.
  22. Francke AL, Smit MC, de Veer AJE, Mistiaen P. Factors influencing the implementation of clinical guidelines for health care professionals: A systematic meta-review. BMC Med Inform Decis Mak 2008;8, (38).
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