Clinical Practice Guidelines Antenatal care - Module I

C. Process report

Page last updated: 02 April 2013

Background

The development of national evidence-based antenatal care guidelines was one of four projects to improve child health and wellbeing approved in July 2005 by the Australian Health Ministers’ Conference (AHMC) and the Community and Disability Services Ministers’ Conference (CDSMC).

During 2006, a National Working Group engaged Women’s Hospitals Australasia (WHA) to develop a report on existing antenatal care guidelines and how they might be adapted to Australian circumstances. This work was developed in consultation with key stakeholder groups across Australia. The report was endorsed by AHMC and CDSMC in July 2006. Ministers recognised, however, the need for further work to develop a guideline document that would be suitable for distribution and one that followed the key principles and processes outlined in the document NHMRC Standards and Procedures for Externally Developed Guidelines (2007).

At this time the value of high quality antenatal care guidelines was recognised by the Council of Australian Governments (COAG) as an important part of the work undertaken by the COAG Human Capital Reform Agenda and the AHMC Maternity Collaboration project. More recently, antenatal care, and the importance of providing nurturing environments for children, underpins key elements of the productivity focus and work program of COAG, including the National Early Childhood Development Strategy. In addition, antenatal care for Aboriginal and Torres Strait Islander women and their families is a key element of the ‘Closing the gap in Indigenous life expectancy’ policy platform, being progressed through COAG, via the Indigenous Early Childhood Development National Partnership.

Governance

This project is co-sponsored by the Child Health and Wellbeing Subcommittee (CHWS), a subcommittee of the Australian Population Health Development Principal Committee (APHDPC) and the Maternity Services Inter-Jurisdictional Committee (MSIJC), a subcommittee of the Health Policy Priorities Principal Committee of the Australian Health Ministers’ Advisory Council (AHMAC).

Objectives

The key objectives of the Guidelines, as approved by the APHDPC in February 2008 were to:
  • undertake a systematic review of national and international literature on antenatal care and antenatal care guidelines to systematically identify and synthesise the best available scientific evidence on antenatal care;
  • appraise and collate evidence on antenatal care and apply it to the Australian context;
  • consider economic factors in aspects of care, for example cost effectiveness of proposed interventions, and identify future research trends;
  • ensure appropriate stakeholder consultation throughout process;
  • draft a set of antenatal care guidelines which are approved by the NHMRC; and
  • make recommendations for the implementation and ongoing maintenance of the Guidelines.

Consultative principles

The following principles underpinned the project’s consultative approach:
  • each stage of the project was developed and completed at the direction of the EAC;
  • the methodology for each stage of the project was developed in consultation with the NHMRC Guidelines Assessment Register (GAR) consultant until 30 June 2010. Further advice was sought from NHMRC where required;
  • extensive consultation (via email, secure website portal, teleconferences and face-to-face meetings) with key academics and professionals in the field and Aboriginal health workers and health professionals involved in antenatal care informed each element of the Guidelines and the development of consensus-based recommendation (where evidence was weak or lacking) and practice points (for aspects of care beyond the scope of the systematic literature review); and
  • implications for implementation, including resource implications, cultural diversity, equity and access to services, informed the Guideline’s recommendations to ensure that these can be achieved in a range of care contexts across Australia.
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Cultural considerations — antenatal care for Aboriginal and Torres Strait Islander women

With a view to improved health outcomes for Aboriginal and Torres Strait Islander women and babies, a key objective was to ensure that the Guidelines are relevant, appropriate and applicable to Aboriginal and Torres Strait Islander women. To achieve this objective the EAC implemented the following strategies:
  • establishment of an Aboriginal and Torres Strait Islander Women’s Antenatal Care Working Group to provide advice and guidance to the EAC throughout the guideline development process;
  • inclusion of discussion about cultural safety for Aboriginal and Torres Strait Islander women;
  • inclusion of specific input/advice relevant to identified characteristics or risk factors for pregnant Aboriginal and Torres Strait Islander women;
  • review of the wording and expression of all recommendations to ensure they are inclusive of the needs and experiences of Aboriginal and Torres Strait Islander women;
  • identification of any available sources of evidence to inform recommendations for Aboriginal and Torres Strait Islander women, with specific reference to the AHMAC Cultural Respect Framework;
  • formulation of specific recommendations for Aboriginal and Torres Strait Islander women where this is possible from available reviews of evidence;
  • articulation of current gaps in evidence that would inform the development of a full range of recommendations required specifically for Aboriginal and Torres Strait Islander women;
  • consultation on the draft Guidelines with relevant Aboriginal and Torres Strait Islander stakeholders; and
  • articulation of implementation issues relevant to Aboriginal and Torres Strait Islander women and those providing antenatal care.

Overview of methodology

The methods and tools used in the development of the Guidelines built on the National Working Group report, completed by the WHA in 2006, used the ADAPTE Manual for Guideline Development Version 1.0 (2007) to identify a reference guideline and thereafter followed the key principles and processes outlined in the document NHMRC Standards and Procedures for Externally Developed Guidelines (2007). The key steps in the guideline development process are outlined in Table C1.

Table C1: Key steps in the guideline development process

1. Initial detailed scope of the Guidelines identified including topics to be included and research questions
2. Systematic search undertaken for existing antenatal care guidelines in the national and international arena
3. Retrieved guidelines screened to select guidelines for further appraisal
4. AGREE appraisals of selected guidelines completed
5. Guideline(s) to use as a reference determined
6. Reference guideline(s) currency assessed
7. Topics and research questions prioritised to finalise scope and cross referenced with questions and recommendations from reference guideline
8. Reference guideline(s) content (recommendations matrices) assessed
9. Systematic literature search and review undertaken to: answer research questions not covered in the reference guideline; and update evidence tables (where new evidence exists).
10. Evidence tables prepared using reference guideline evidence and updated evidence (if relevant) following the key principles and processes outlined in the document NHMRC Standards and Procedures for Externally Developed Guidelines (2007).
11. Topics and questions that require economic evaluation identified and work contracted.
12. EAC provided with evidence tables (comprising reference guideline evidence and recommendations and updated evidence) and Evidence Statement/ Matrix (adapted from NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines [2009]).
13. Evidence tables and evidence statement reviewed by EAC and advice provided on clinical impact and implementation issues, including applicability to the Australian context.
14. Where evidence was sufficient to support recommendations, recommendations formulated and graded by EAC.
15. Where evidence was weak or lacking, consensus-based recommendations formulated by EAC.
16. Where advice was needed but the area was beyond the scope of the literature review, practice points developed by EAC.
17. Draft Guidelines, a document that respects the needs of the end users and provides a detailed transparent explanation of the process and with implementation issues considered, prepared.
18. Draft Guidelines reviewed by EAC.
19. Draft Guidelines reviewed by Working Group for Aboriginal and Torres Strait Islander Care Women’s Antenatal Care and additional practice points developed.
20. Public consultation (advertisement, available on Health and NHMRC website, mail-out, email alert to relevant stakeholder organisations) conducted for a period of 30 days.
21. Guidelines updated and summary document outlining response to each submission developed.
22. Draft Guidelines approved by EAC and provided to CHWS and MSIJC for clearance.
23. Submitted to the NHMRC for independent methodological and peer review and consideration for approval.
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Managing conflict of interest

A robust and transparent system was used to manage conflict of interest throughout the development of the draft Guidelines. All members were asked to complete declaration of interest forms before acceptance onto the EAC, and requested to advise the Chairs of the EAC of any competing interests if these arose during the development of the Guidelines. A review of potential conflicts of interest was undertaken at every committee meeting.

The only conflicts of interest identified involved members being authors of studies included in the evidence base for a recommendation. When this was the case, this was noted and the member did not participate in grading of the evidence.

Process

The development of the draft Guidelines has followed the key principles and processes outlined in the document NHMRC Standards and Procedures for Externally Developed Guidelines. For more information please visit National Health and Medical Research Council website.

The ADAPTE framework was used to identify and appraise relevant international and national guidelines. Following appraisal of identified guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE) instrument, the NICE (2008) Antenatal Care. Routine Care for the Healthy Pregnant Woman were selected as a reference guideline. Following review of the evidence (see Appendix D), the grading of evidence and recommendations followed the NHMRC Levels of Evidence and Grades for Recommendations for Developers of Guidelines (NHMRC 2009). Consensus by the EAC on the grading of the systematic literature review evidence was achieved for all items and recorded in detailed summary sheets used to form the basis of the EAC’s decisions about which recommendations were appropriate to develop, and the subsequent grading of these recommendations.

Consensus-based recommendations were developed where insufficient evidence was identified to support a recommendation.

Practice points (PPs) were developed to cover areas that were beyond the scope of the systematic literature reviews but where practical advice is needed.

The process of the systematic literature reviews is discussed in more detail in Appendix D.

Public consultation

The draft Guidelines were released for a 30-day public consultation, as required in the NHMRC Act, 1992 (as amended), on 28 May 2011. Submissions were received from health departments, non-government organisations, health services and individuals, with a total of 55 submissions. Key issues and how these were addressed are outlined below.
  • A number of submissions raised the need for guidance to be included within the Guidelines rather than readers being referred to other guidelines. Summaries of the perinatal mental health, alcohol and iodine guidelines have therefore been included. Other topics suggested — nutrition, breastfeeding and physical activity — are being reviewed for inclusion in Module II of the Guidelines.
  • Some submissions suggested that more emphasis be given to the environment of the developing baby, including differing experiences of pregnancy, partner/family involvement in antenatal care and education and child protections issues. This has been included where relevant.
  • There was considerable support for coverage of issues relevant to women from culturally and linguistically diverse backgrounds throughout the document. The existing discussion of improving the experience of antenatal care for these women has been expanded based on information provided in submissions and additional resources included. The development of Module II of the Guidelines will be informed by a working group representing women from culturally and linguistically diverse backgrounds.
  • A number of submissions suggested inclusions for the content of the first antenatal visit and for the suggested schedule of visits. Discussion of the first antenatal visit has been expanded. As evidence concerning antenatal care beyond the first trimester was not reviewed and many topics included are being reviewed to inform Module II of the Guidelines, it was agreed to remove the schedule.
  • While there was some support for a recommendation to weigh women at all antenatal visits, a number of submissions raised the point that while there is evidence for poorer outcomes associated with low or high weight gain, there is no evidence for the effectiveness of screening in improving outcomes. The recommendation has been replaced with the NICE recommendation to repeat weighing when clinical management is likely to be influenced. Submissions also requested guidance on weight gain. The IOM advice, which is already in use in some jurisdictions, is specified.
  • Some submissions queried the criteria in the recommendation on repeat testing for proteinuria. It was agreed that the recommendation be removed as the literature in this area had not been reviewed. This will be included in the review to inform Module II of the Guidelines.
  • Some submissions suggested that hepatitis C should be a routine screen and others noted the incongruity in recommending against screening but offering screening before an invasive procedure when it is hard to predict whether procedures will be required during labour. It was agreed that the evidence only supports selective screening due to the lack of effective treatment options. The point on screening before invasive procedures (specifically chorionic villus sampling and amniocentesis) has been retained due to the potential risk to the fetus.
  • Responses to selective screening for vitamin D deficiency were mixed; one submission suggested universal screening, some suggested reducing the current criteria and others expanding them. It was agreed that the included recommendation was supported by the evidence. A number of submissions questioned the recommendation on vitamin D supplementation, either due to the costs involved or the dose recommended. Due to the lack of evidence on outcomes, harms and benefits, it was agreed to remove the recommendation.
  • Some submissions questioned the evidence base and accuracy of the section on chromosomal abnormalities. The evidence for this section has been reviewed and the section rewritten based on the advice provided.
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Implementation

The following multidisciplinary team will contribute to the design and execution of strategies aiming to increase the uptake of the Guidelines through liaison with their professional groups and promotion of the recommendations:
  • Assoc Prof Ruth Stewart (EAC, Director Parallel Rural Community Curriculum, School of Medicine Deakin University, Australian College of Rural & Remote Medicine Representative);
  • Prof Susan McDonald (EAC, Professor of Midwifery La Trobe University/ Mercy Hospital for Women);
  • Dr Andrew Bisits (EAC, Lead Clinician, Birthing Services, Royal Hospital for Women, Sydney);
  • Ms Ann Catchlove (EAC, consumer representative);
  • Ms Debra Reid, Senior Adviser, Office of Aboriginal and Torres Strait Islander Health;
  • Assoc Prof Danielle Mazza, Department of General Practice, Monash University;
  • Prof Sally Green, methodological consultant, Co-Director Australasian Cochrane Centre, Monash University; and
  • Ms Sue Hendy (EAC, Director of Women’s, Children’s and Youth Health, Nepean Blue Mountains and Western Sydney Local Health Networks).
Professor Jeremy Oats (Chair Victorian Consultative Council on Obstetric and Paediatric Mortality and Morbidity, Medical Co-Director Integrated Maternity Services, Northern Territory) and Professor Caroline Homer (Professor of Midwifery, Child and Family Health University of Technology, Sydney) will act as ex officio members. Members of the Working Group for Aboriginal and Torres Strait Islander Women’s Antenatal Care will contribute to the implementation plan for the Guidelines, because of the need to specifically consider and develop strategies for implementation in the full range of specific settings and contexts where Aboriginal and Torres Strait Islander women receive care.

The EAC includes a number of members in positions of influence within various organisations and government departments. Similarly, the Maternity Services Inter-jurisdictional Committee and Child Health and Wellbeing Subcommittee members are well-placed to affect change in clinical and regulatory environments.

Key messages for dissemination and implementation

Central to the dissemination and implementation plan is the identification of key messages resulting from the Guidelines, which will be prioritised for communication and implementation. High priority will be given to recommendations that have:
  • strong evidence underpinning the recommendation;
  • an identified gap or need for a change to current practice;
  • an identified burden of care including the number of women and babies likely to be affected by implementation of the recommendation; or
  • cost implications
Key priorities for the Australian context will be based on identified gaps in current practice and where wide variations in clinical practice currently exist.

Dissemination formats

The Guidelines will be accompanied by a range of dissemination products published in varying formats to meet the needs of different target audiences. These are likely to include:
  • summaries (in a range of languages) for women and their families;
  • summaries for health professionals; and
  • a guide for health care workers in Aboriginal and Torres Strait Islander communities.
The Guidelines will be published on the DoHA website.

Implementation strategies: facilitating uptake of the disseminated Guidelines

A range of strategies, harnessing the multidisciplinary team of opinion leaders involved in the development of the Guidelines, will be employed, informed in some cases by an assessment of the likely barriers to uptake of the prioritised recommendations. Potential implementation strategies include:
  • education through meetings, conferences and presentations;
  • outreach education; and
  • opinion leaders — EAC endorsement.
Key messages from the Guidelines may also be implemented through a number of existing initiatives. (eg Pregnancy life scripts).
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Monitoring uptake of the Guidelines

The extent to which the Guidelines have influenced practice and policy will be monitored in a number of ways. Selected indicators are reported on annually by all States and Territories, through the National Policy Response to the Children’s Headline Indicators.
  • The Headline Indicators for Children’s Health, Development and Wellbeing of the AHMC, the CDSMC and the Australian Education, Early Childhood Development and Youth Affairs Senior Officials Committee provides measurements suitable for defining the current situation. Indicators related to antenatal care are: smoking in pregnancy; low birth weight; and infant mortality (noting that this indicator measures the number of deaths of live-born infants less than one year of age).
  • The Australian Institute of Health and Welfare also publishes a number of indicators in this area (eg infant mortality rate).
  • The COAG “Closing the Gap” initiative provides indicators relevant to antenatal care for Aboriginal and Torres Strait Islander people.
The indicators and methods for monitoring are under development.