Principles

for the
development of Guidance/
Procedures

Dwi Izzati Budiono

Midwifery Study Programme Faculty of Medicine - Universitas Airlangga
Modul Pembekalan COVID-19

FK Universitas Airlangga – Surabaya, 2020 1

Outline

•  Terms (common terms) and definition

•  Aims
•  Laws and policies
•  How to produce guidance
•  Principles for the development of SOP: social judgment
•  Midwifery model of care

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Term and definition

Standard Operating Procedures (SOP) adalah serangkaian instruksi

tertulis yang dibakukan mengenai berbagai proses penyelenggaraan
administrasi pemerintah (Kepmenpan No.021 tahun 2008).

Standar Operasional Prosedur (SOP) adalah suatu perangkat instruksi/
langkah-langkah yang dibakukan untuk menyelesaikan proses kerja
rutin tertentu. Istilah ini digunakan di Undang-undang No. 29 Tahun
2004, tentang Praktik Kedokteran dan Undang-undang No. 44 Tahun
2009,tentang Rumah Sakit.

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Common terms
•  Prosedur yang telah ditetapkan disingkat protap,
•  Prosedur untuk panduan kerja (prosedur kerja, disingkat PK)
•  Prosedur untuk melakukan tindakan,
•  Prosedur untuk penatalaksanaan,
•  Petunjuk pelaksanaaan disingkat Juklak,
•  Petunjuk pelaksanaan secara teknis, disingkat Juknis,

•  Prosedur untuk melakukan tindakan klinis : protokol klinis, algoritma/
clinical pathway

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Common terms

Karena beraneka ragamnya istilah tentang prosedur dan untuk

menghindari salah tafsir serta dalam rangka menyeragamkan
istilah “standar operasional prosedur“ (SOP) sebagaimana yang
tercantum dalam Permenpan Nomor 35 tahun 2012.

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Recent laws and policies
•  UU Nomor 36 Tahun 2009 tentang Kesehatan
•  UU Nomor 36 Tahun 2014 tentang Tenaga Kesehatan
•  Permenkes Nomor 28 Tahun 2017 tentang Izin dan Penyelenggaraan
Praktik Bidan
•  UU Nomor 4 Tahun 2019 tentang Kebidanan
•  Permenkes Nomor 83 Tahun 2019 tentang Registrasi Tenaga
Kesehatan
•  Kepmenkes Nomor 320 tahun 2020 tentang Standar Profesi Bidan

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Aims

•  Agar berbagai proses kerja rutin terlaksana dengan efisien,

efektif, konsisten dan aman, dalam rangka meningkatkan
mutu pelayanan melalui pemenuhan standar yang berlaku
•  Memberikan perlindungan dan kepastian hukum kepada
bidan dan klien
•  Meningkatkan derajat kesehatan masyarakat, terutama ibu,
bayi baru lahir, bayi, balita, dan anak prasekolah.

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How to produce guidance?

•  Prepare guidance and standards on topics that reflect national

priorities for health care
•  Describe approach in process and methods manuals, and review them
regularly
•  Use independent advisory committees to develop recommendations
•  Take into account the advice and experience of people using services
and their carers or advocates, health and social care professionals,
commissioners, providers and the public
•  Offer people interested in the topic the opportunity to comment on
and influence the recommendations
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What we take into account?

Use evidence that is relevant, reliable and robust

•  Guidance and standards are underpinned by evidence. We need
to ensure that this evidence is relevant, reliable and robust. To
do this, we need to identify research evidence, determine
whether it is relevant and assess its quality. We need to work
with data providers to ensure the information and data analytics
that we use are high quality and robust.
•  For each piece of guidance, we need to consider whether the
methodology used to produce the evidence is appropriate.

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What we should take into account?

•  We need to recognise the value of traditional ‘hierarchies of

evidence’ but take a comprehensive approach to assessing the
best evidence that is available to answer the questions we face.
The process and methods manuals set out the types of evidence
that are generally appropriate for different types of question.
This can include qualitative and quantitative evidence, from the
literature or submitted by stakeholders. It can also include
observational data and testimonies from experts.

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What we should take into account?

•  Committees should not recommend an intervention if there is no

evidence, or not enough evidence, on which to make a clear
decision. But they may recommend using it in a research
programme or alongside mandatory data collection, if this will
provide more information about its effectiveness, safety or cost

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Why do we need evidence?
Need
•  Information overload (e.g. >50 trials and >2000 research articles published every
day!)
•  Challenging ritual, habit, routine
•  Responding to consumer demands
•  Responding to cost pressures and demands on health systems
•  Responding to patient safety agenda and developments in clinical governance
•  Meeting obligations of professional codes of conduct

Purpose
•  To provide care that is:
Ø safe and clinically effective
Ø cost effective
Ø Valued, respectful and important for patients and communities

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Hierarchy of evidence

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Steps of Evidence Based Health Care

•  Asking question
•  Finding the evidence
•  Apprasing and interpreting evidence
•  Acting on evidence
•  Evaluation and reflection

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Steps of Evidence Based Health Care
Stages
Asking a relevant question
Finding the evidence
Appraising the quality of the Being able to use tools and
evidence and assessing its
applicability to your own
context and patients
Acting on the evidence
Evaluation of change
Skills
How to create a well
structured question
How to search for literature
principles of critical
appraisal
Using methods of change
management, guideline
development and quality
improvement
Undertaking service
evaluation and clinical audit
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Evidence changing practice

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Principles for the development of guidance

Two types of judgments needed:

•  Scientific value judgments
•  Social value judgments

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Principles of Bioethics

Moral principles:
•  Respect for autonomy
•  Non-maleficence
•  Beneficence
•  Distributive justice.

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Principles of Bioethics

Distributive justice:
•  Utilitarian approach, involves allocating resources to maximise
the health of the community as a whole. It allows an efficient
distribution of resources, but sometimes at the expense of
fairness.

•  Egalitarian approach, involves distributing healthcare resources
to allow each individual to have a fair share of the opportunities
available, as far as is possible.

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Principles of Bioethics

Procedural justice:
•  Publicity
•  Relevance
•  Challenge and revision
•  Regulation.

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Fundamental Operating Principles
•  Scientific rigour
•  Inclusiveness
•  Transparency
•  Independence
•  Challenge
•  Review
•  Support for implementation
•  Timeliness

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Evidence-Based Decision Making
Clinical and public health effectiveness
•  Should not recommend an intervention (that is, a treatment,
procedure, action or programme) if there is no evidence, or not
enough evidence, on which to make a clear decision.
•  But advisory bodies may recommend the use of the intervention
within a research programme if this will provide more information
about its effectiveness, safety or cost.

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Evidence-Based Decision Making
Cost effectiveness
•  Those developing clinical guidelines, technology appraisals or public health
guidance must take into account the relative costs and benefits of
interventions (their ‘cost effectiveness’) when deciding whether or not to
recommend them.
•  Accessing cost effectiveness can be done by comparing its cost against the
gain in health outcome (benefit) it is expected to provide. QALY?
•  Decisions about whether to recommend interventions should not be based
on evidence of their relative costs and benefits alone. We must consider
other factors when developing guidance, including the need to distribute
health resources in the fairest way within society as a whole.

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Evidence-Based Decision Making
Individual choice
•  Although we accept that individual users will expect to receive
treatments to which their condition will respond, this should not
impose a requirement on advisory bodies to recommend
interventions that are not effective, or are not cost effective enough
to provide the best value to users of the system as a whole.

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Responding to comments and criticism
Principle:
•  Should consider and respond to comments it receives about its draft
guidance, and make changes where appropriate. But advisory bodies
must use their own judgment to ensure that what it recommends is
cost effective and takes account of the need to distribute health
resources in the fairest way within society as a whole.

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 Continuity of Care
Less likely More likely

Epidural Spontaneous
anaesthesia births

Instrumental Breastfeed-
births ing

Episiotomy Satisfied

BENEFITS 26
ICM Model of Midwifery Care
•  Midwives promote and protect women’s and newborns’
health and rights.
•  Midwives respect and have confidence in women and in
their capabilities in childbirth.
•  Midwives promote and advocate for non-intervention in
normal childbirth.
•  Midwives provide women with appropriate information and
advice in a way that promotes participation and enhances
informed decision-making.
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ICM Model of Midwifery Care
•  Midwives offer respectful, anticipatory and flexible care,
which encompasses the needs of the woman, her newborn,
family and community, and begins with primary attention to
the nature of the relationship between the woman seeking
midwifery care and the midwife.
•  Midwives empower women to assume responsibility for
their health and for the health of their families.
•  Midwives practice in collaboration and consultation with
other health professionals to serve the needs of the woman,
her newborn, family and community.
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ICM Model of Midwifery Care
•  Midwives practice in collaboration and consultation with other
health professionals to serve the needs of the woman, her
newborn, family and community. Midwives maintain their
competence and ensure their practice is evidence-based.
•  Midwives use technology appropriately and effect referral in a
timely manner when problems arise.
•  Midwives are individually and collectively responsible for the
development of midwifery care, educating the new generation
of midwives and colleagues in the concept of lifelong learning.

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Antenatal role of the midwife

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Being-Doing

•  Woman-centred care (Leap, 2009)

•  Woman’s autonomy and skills (Walsh, 2009)
•  Being with, not doing to (Fahy, 1998)
•  The less we do, the more we give (Leap, 2000)
•  Doing nothing well (Kennedy, 2000)
•  Midwife as guest (Pembroke & Pembroke, 2008)

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Partnership

Process of teamwork between a woman, her partner or

significant others and the midwife, working towards a shared
goal (Fontein, 2009).

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Soo Downe, 2012

“Midwifery knowledge at its best recognises unique normality,

responds ahead of absolute emergencies, constantly assesses
the complex situation of a birth, pregnancy or postnatal
episode, and constantly factors in the woman herself , her
family culture and her particular philosophies, ideals, hopes and
aspirations, as well as the formal evidence base”

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 Midwives
Defenders of women’s right
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References
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•  Walsh D (2012) Evidence and Skills for Normal Labour & Birth: A Guide for Midwives. London: Routledge
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References
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•  ICM. 2014. Core Document. Philosophy and Model of Midwifery Care
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