Transcript Clinical (Practice) Guidelines

Clinical Practice Guidelines
Sudigdo Sastroasmoro
Konsorsium Upaya Kesehartan
Ditjen BUK Kemenkes RI
Peningkatan Mutu Pelayanan
Telah dilakukan sejak zaman prasejarah
Cenderung sektoral, tidak komprehensif
Konsep di UK: Clinical governance
Diadopsi / dikembangkan di semua negara
dengan pelbagai nama
Clinical Governance
"A framework through which NHS
organizations are accountable for
continuously improving the quality of their
services and safeguarding high standards of
care, by creating an environment in which
excellence in clinical care will flourish."
Patient safety
Clinical audits
Education
& Training
Risk
management
Clinical
audits
Clinical
Governance
Clinical
Effectiveness
Accountability
Research &
development
EBM:
# HTA
# Clinical guidelines
# Clin pathways
# Algorithms
# Protocols
# Procedures
#Standing orders
Introduction
Improvement of quality of care should be
continuously planned, implemented, and evaluated
Rapid science and technology development has
tremendous effects on its implementations
EBM is a good paradigm (originally) at the level
of individual professional caring individual patient
For certain diseases or problems, standardized
patient care is mandatory
“Hierarchy” in clinical medicine
Researchers offer what we can do to solve problem
in clinical medicine
Health technology assessment (HTA) assesses which
of the offers can be implemented (which we can do)
Clinical practice guidelines select one to implement
in a particular hospital or clinic (what we should do)
Practitioners implement what we should do (doing
what we should do)
Clinical audits assess if we have done what we
should do (did we do what we should do)
EBM Practice
Evidence
Physician’s proficiency
Patient’s preference
The EBM Paradigm
Health care
problem
Recommendation
Critically
appraise
the evidence
Formulate
in answerable
question
Search the
evidence
Taxonomy of health system standards
(Ashton, 2002)
Clinical practice guidelines
Clinical pathways
Protocols
Procedures
Algorithms
Standing orders
Must be:
# Evidence-based
# Periodically
revised
The jungle of terms
Standar pelayanan, standar pelayanan
kedokteran, standar pelayanan kesehatan,
standar prosedur operasional, prosedur
operasional standar, standar profesi, standar
fasilitas, standar pelayanan medis, pedoman
pelayanan medis, panduan pelayanan medis,
panduan praktik klinis, prosedur baku, etc etc.
Juliet Capulet:
What’s in a name?
A rose by any other name
would smell as sweet
The Merchant of Venice – W. Shakespeare
Standardization of terms
Taxonomy of Health System Standards (modification):
– National Guidelines / Pedoman Nasional Pelayanan
Kedokteran (PNPK)
– Clinical Practice Guidelines /Panduan Praktik Klinis
(PPK)
• Clinical pathways
Please note that
• Algorithms
there is no “standard”
• Protocols
term at the level
• Procedures
of healthcare
facilities
• Standing orders.
Note:
In the following slides:
PNPK (Pedoman Nasional Pelayanan Kedokteran)
refers to National Clinical Guidelines,
while
PPK (Panduan Praktik Klinis) refers to Clinical
Guidelines at healthcare facility level
Pedoman Nasional Pelayanan Kedokteran
(PNPK)
PNPK is a systematic statement, evidence-based, to help
practitioners and patients to cope with certain clinical
conditions. Synonyms: clinical guidelines, clinical practice
guidelines, practice parameters.
In the literature the term Clinical (Practice) Guidelines are
used to national / global a as well as local setting
In Indonesia:
– Documents developed by experts and endorsed by the
Government are called National Guidelines (PNPK),
– After adaptation to specific healthcare facility is called
Clinical Practice Guidelines (PPK) and other local
instruments, which are as a whole called as standard
operating procedures (UUPK) .
Who should develop PNPK?
In theory everyone can do it: Minister, Dean,
Director, professional organization, etc
”US Model” – experts, without government
endorsement
”British Model” – experts, with government
endorsement
Indonesia - British Model
When is PNPK needed?
PNPK is needed in conditions with:
– Large number of subjects (high volume)
– Tends to have a high risk (high risk)
– Requires high resources, esp. cost (high cost)
especially when there are large variations
among the practicing professionals in the
management of the same disease or problem
(high variability).
Characteristics of PNPK
Valid
Reproducible
Effective and cost-effective
Representative, frequently multidisciplinary
Can be applied in daily practice
Flexible
Clear
Scheduled for revisions
Can be used as a parameter for clinical audits
PNPK Development Process
Selection of topic of interest
– MOH sends letter to Deans, Directors of Teaching
Hospitals, professional organizations to submit the
topic
– Initial selection
– Complete proposal
– Determine priorities
PNPK Development Process
Developing Expert Panel
– Academicians, Professional organizations
– Introducing process:
• Purpose of PNPK development
• Format of PNPK
• Methods, time-table, etc
• Appointments of Chair, Co-Chair, Secretary,
etc
PNPK Development Process
Initial drafting, follow-up, and meetings
– Initial draft is usually prepared by assistants
(newly graduated doctors under the supervision
of Chair)
– Further developed by means of emails
– Monthly meetings
– Completed after 2-4 meetings
– Director General / MOH
PNPK format
A standardized book of PNPK is available,
subject for modification of color, fonts, etc
Logo of MOH is displayed on the cover
Logos of professional organizations involved
are printed on the cover
Experts directly involved in the process are
written as contributors
Content of PNPK (may be modified as needed)
Executive Summary
Background
– Justification why PNPK is needed
Methods
– Search Strategy, keywords etc
– Criteria for Inclusion and Exclusion
– Levels of Evidence
– Grades of Recommendations
Results and Discussion
Conclusions / Recommendations
References
Appendices
Examples of Clinical Practice Guidelines ∞
American Association of Clincal Endocrinologists. Medical
Guideline for Clinical Practice for the Management of Diabetes
Mellitus. 67 halaman, ratusan rujukan (dibuat terpisah per topik
bahasan).
http://www.aace.com/pub/pdf/guidelines/DMGuidelines2007.p
df
American Academy of Pediatrics. Clinical Practice Guideline:
Diagnosis and Evaluation of the Child With AttentionDeficit/Hyperactivity Disorder. 13 halaman, 60 rujukan.
http://aappolicy.aappublications.org/cgi/reprint/pediatrics;105
/5/1158.pdf
Guideline for Alzheimer’s Disease Management. Final Report
2008. Supported by the State of California, Department of Public
Health. California Version © April 2008. 57 halaman plus
apendiks, total 122 halaman, lebih dari 300 rujukan.
http://www.caalz.org/PDF_files/Guideline-FullReport-CA.pdf
ACC/AHA 2008 Guidelines for the Management of Adults
With Congenital Heart Disease: Executive Summary. 49
halaman, 202 rujukan.
http://circ.ahajournals.org/cgi/reprint/118/23/2395
Americal College of Cardiology / American Heart Association
(2002): Guideline update for the management of chronic
stable angina. 136 halaman, 1053 rujukan
MOH Malaysia. Clinical Practice Guidelines Management of
Dengue Fever in Children, 2005. 22 halaman, 33 rujukan.
http://www.acadmed.org.my
Malaysian Society of Neurosciences, Academy of Medicine
Malaysia, Ministry of Health Malaysia. Clinical practice
guidline. Management of stroke. 37 halaman, 150 rujukan.
http://www.acadmed.org.my
Indeks untuk pelbagai jenis CPG di Malaysia dapat diakses
melalui http://www.acadmed.org.my/index.cfm?&menuid=67
Singapore MOH Clinical Practice Guideline 2004.
Management of atrial fibrillation. 70 halaman total, 83
rujukan. http://www.moh.gov.sg/cpg
Clinical Practice Guidelines (PPK)
PNPK must be translated into specific conditions of the
local settings; the result is PPK
PPK may similar or differ in different hospitals
– PPK for DHF without shock maybe similar in type A, B,
C, D hospitals or community health centers
– In one Type A Hospital PPK for congenital heart
disease includes diagnosis until surgery, but in other
type A hospital only limited to diagnosis
– PPK for stroke in type B hospital who has neurosurgeon
differs from those who does not have neurosurgeon.
PPK is hospital specific.
Objectives of PPK
To improve quality of care in certain clinical
conditions and environment
To reduce unnecessary procedures or
interventions
To provide best treatment with maximal benefits
to patients
To provide treatment option with minimal risk
Patient management with appropriate cost
PPK for other diseases or conditions
For diseases or conditions which do not meet the
PNPK criteria, or no PNPK is available, the medical
staff should develop PPK referring to:
– Recent literature (primary reports, systematic review
/ metaanalysis, etc)
– Textbooks / Evidence-based textbooks
– CGL from other countries
– Guidelines of professional organizations, certain
directorates of MOH, etc
– Medical staff consencus
PPK is developed under the coordination of Medical
Staff Committee, and valid after Director’s approval
Specific instruments to support PPK
PPK may require specific instruments:
– Ischemic stroke: need multidisciplinary care with
predictable clinical course: clinical pathway
– Chronic kidney disease requiring hemodialysis:
protocol for hemodialysis
– Complex febrile convulsion subject for lumbar
puncture: lumbar puncture procedure
– Simple febrile convulsion requiring rectal
diazepam by nurse in the absence of physician:
standing orders.
Clinical Pathway (CP)
CP = care pathway, care map, critical pathway,
integrated care pathways, multidisciplinary pathways of
care, pathways of care, collaborative care pathways.
CP details what should be done in certain clinical
condition. CP is a day to day plan of patient
management
CPs use multidisciplinary approach, so that averyone
could use the same format
Patient’s progression can be monitored on daily basis,
including intervention and its outcomes
CP is best suite for conditions with predictable clinical
course and need multidisciplinary care
Any deviation from the expected outcome = variance
A clinical pathway (CP) is a “task-oriented care plan
that details essential steps in the care of patients with
a specific clinical problem and describes the patient’s
expected clinical course.”
The term CP is often used interchangeably with clinical
guideline and clinical protocol. While the differences
between pathways, guidelines and protocols are
subtle, the distinction is important. Five characteristics
of clinical pathways have been agreed upon that
differentiate them from guidelines and protocols:
1.
2.
3.
4.
5.
A CP is a structured multidisciplinary plan of care;
CPs are used to channel the translation of guidelines or
evidence to the bedside;
A CP details the steps in a course of treatment or care
in a decision tree or other inventory of actions;
CPs have timeframes or criteria-based progression (i.e.,
steps are taken if designated criteria are met), and
CPs are intended to standardize care for a specific
clinical problem, procedure or episode of healthcare in
a specific population.
What is a Clinical Pathway?
A Clinical Pathway is a plan of care, drafted in
advance for predictable patient groups which is
developed and used by multidisciplinary team.
It forms part of the written documentation,
includes outcomes to be achieved and the
capacity for recording and analysing variance.
The Royal Children’s Hospital
Melbourne, Australia
Should CP be develop for all diseases?
No
Approximately 30% of hospitalized patients
are managed using CP; the rest are managed
using usual care
CP is most appropriate when applied to
conditions that need multidisciplinary care and
the clinical course is predictable
Are CPs developed to fit financial needs?
No
CP may reduce hospital cost
CP data could be used for other programs related to
finance, e.g., diagnostic related group (DRG), casebased group (CBG), etc
CP should not be developed to determine hospital
cost so that all diagnosis should have CP. Otherwise
CP is not patient-oriented but DRG-oriented or length
of stay oriented.
Can we develop CP for other diseases
or problems?
CP - is a standardized management for certain
group of patients
If the clinical course varies, it is impossible to develop
day-to-day plan of care
However CP can be develop provided:
• Clear inclusion and exclusion criteria,
• Patient being managed using CP should be switch to
usual care if tehre is co-morbidity or complication
The decision lies on the professionals.
Example: CP for acute diarrhea
Inclusion criteria (all must be met)
– Age 1-5 years
– Acute diarrhea without complication / co-morbidity
– Dehydration <10%
– No indication for surgery
Exclusion criteria (any of these):
– Immunocompromized patients
– Vomiting or abdominal pain without diarrhea
– Diarrhea >5 days
Should be excluded from CP if:
– No clinical improvement in 48 hrs
– Biliary vomiting wirh abdominal pain
– Questionable diagnosis
Algorithms
“Algorithms are written in the format of a
flowchart or decision tree. This format provides
a quick visual reference for responding to a
situation. For instance, algorithms are effective
in emergency departments and critical care
units. When staff are faced with an emergency,
such as a patient hemorrhaging, they can treat
the patient rapidly by following the algorithm”.
Ashton, 2002
Protocols
Protocols define patient care management for
specific situations or conditions. Protocols may be
written for the care of patients who have
indwelling tubes (e.g., nasogastric, urinary
catheter). Thus, the procedure would describe how
to insert the tube and the protocol would describe
how to care for the patient with a tube in place.
Standards might include how often to assess the
patient, what to assess, and what types of
treatments are needed. Protocols may also be
written for patient categories, e.g., maternity care.
Procedures
“Procedures are step-by-step instructions on
how to perform a technical skill. This format
often involves the use of equipment,
medication, or treatment. Examples of
procedures include how to administer blood,
insert tubes (nasogastric, urinary catheters),
administer medication (oral, rectal,
intravenous), administer tube feedings, perform
suctioning, and wound care”.
Standing orders
Standing orders are set of physician’s instructions
to nurses or other health professionals to do
something in the absemce of the doctor. Standing
oder can be directed to specific patients or in
general with the approval of medical committee.
Example: certain postsurgical care, administration
of paracetamol in a child with high fever,
intrarectal diazepam for children with seizure, etc.
Implementing guidelines in patient care
PPK should be implemented according to
patient’s condition. PPK should be viewed as
advice or recommendation, not to be
implemented in all patients.
– PPK is developed for ’average patients’.
– PPK is meant for single disease / condition
– Individual variation to diagnostic and therapeutic
procedures
– PPK is vaild when printed
– Modern medical practice requires the accommodation
of patient’s and familiy’s role in clinical decision
making
Disclaimer
Penggunaan Standar Pelayanan Medis / Panduan PM
ini harus disesuaikan secara individual:
PPK is developed for average patients
PPK is developed for single isolated
disease/condition
Individual response to Dx & Rx procedures
Valid at the time of printing
Shared clinical decision making process
51
Applying guidelines to the care
of an individual patient
always requires judgment
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Additional points for disclaimer
CPG is meant to patient care so it does not contain
complete information on disease/health condition
CPG is not the best for all patients
The caring physician should consult to other
professional whenever he or she feels that he or she
is not very confident in establishing diagnosis and
administer treatment
The authors of CPG will not hold responsibility for
whatever results may be by using the CPG
MOH Singapore, Statement of Intent
These guidelines are not intended to serve as a
standard of medical care (SMC).
SMC are determined on the basis of all clinical data
for an individual case and are subject to change as
scientific knowledge advances and patterns of care
evolve.
Adherence to these guidelines may not ensure a
successful outcome in every case. These guidelines
should neither be construed as including all proper
methods of care, nor exclude other acceptable
methods of care.
Disclaimer, RWH Melbourne
Whilst appreciable care has been taken in the
preparation of clinical guidelines which appear on this
web page, The RWH provides these as a service only
and does not warrant the accuracy of these guidelines.
Any representation implied or expressed concerning
the efficacy, appropriateness or suitability of any
treatment or product is expressly negated.
In view of the possibility of human error and / or
advances in medical knowledge, The RWH cannot and
does not warrant that the information contained in the
guidelines is in every respect accurate or complete.
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Disclaimer, RWH Melbourne
Accordingly, The RWH will not be held responsible
or liable for any errors or omissions that may be
found in any of the information at this site.
You are encouraged to consult other sources in
order to confirm the information contained in any of
the guidelines and in the event that medical
treatment is required to take professional, expert
advice from a legally qualified and appropriately
experienced medical practitioner.
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Disclaimer, RCH Melbourne
The emergency paediatric guidelines presented on this
site were developed by RCH clinicians primarily for use
within the inpatient wards and emergency dept of RCH
They detail the initial assessment and management of
many common (and some rare but important) conditions
……
They do not constitute a text-book and therefore
deliberately provide little, if any, explanation or
background to the conditions and treatment outlined.
They are however designed to acquaint the reader
rapidly with the clinical problem and provide practical
advice regarding assessment and management.
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Disclaimer, RCH Melbourne
These CPG were produced by staff of The Depts. of
General & Emergency …..… The CPGs do not necessarily
represent the views of all the clinicians in the RCH.
The recommendations contained in these guidelines do not
indicate an exclusive course of action, or serve as a
standard of medical care. Variations, taking individual
circumstances into account, may be appropriate.
The authors of these CGL have made considerable efforts
to ensure the information is accurate and up to date…...
The authors accept no responsibility for any inaccuracies,
information perceived as misleading, or the success of any
treatment regimen detailed in the guidelines.
Who should decide?
The most responsible person who comprehensively
evaluate the patient’s condition is the doctor in
charge. He or she should determine whether CPG
is applied or not. In the case that the doctor in
charge did not follow the CPG, he or she should
write clearly the reason why in the medical record.
If he/she did not write the reason for not giving
the reason then he / she is committed to neglect
the patient.
The cardinal rule in medical records:
If it isn’t written down,
it didn’t happen
Revisions of PPK
Recent evidence
Periodic revisions
Usually every 2 years
Use of intranet may save money
Clinical Practice Guidelines
Clinical Pathways
Algorithma
Procedures
Protocols
Standing Orders
3/17/10
J Ashton, 2002
PNPK
Literature
Primary articles
Systematic reviews
Guidelines
Textbook, Professional
Organization Guidelines, etc
Consensus
Standard Operating Procedures = PPK
According to
Type and strata
(hospital specific)
Pathways
Algoritms
Protocols
Prosedures
Standing orders
Can be developed
Without awaiting
PNPK
Beberapa pengertian yang perlu
diluruskan/disepakati/kesamaan persepsi:
PNPK
–
–
–
–
–
High volume, high risk, high cost, high variability
Dibuat oleh tim pakar, hampir selalu multidisiplin
Informasi mutakhir, ideal, evidence-based
Disahkan Menteri
Harus diterjemahkan ke fasilitas pelayanan
menjadi PPK (dalam UU-PK disebut sebagai
Standar Prosedur Operasional)
PNPK
Format
– Ringkasan Eksekutif
– Pendahuluan: mengapa diperlukan PNPK
– Metodologi: search strategy, keywords, levels of
evidence, grades of recommendations
– Hasil dan pembahasan
– Rekomendasi
– Daftar pustaka
– Lampiran bila perlu
Perlu waktu beberapa bulan untuk 1 PNPK
Terjadwal untuk revisi
PPK
Bersifat hospital specific
Dibuat dengan rujukan utama PNPK (bila tersedia)
Bila PNPK belum / tidak / tidak perlu ada, PPK dibuat
oleh fasilitas pelayanan dengan merujuk pada
– Literatur mutakhir (artikel asli, SR/meta-analisis, dll)
– Clinical guidelines asing
– Buku ajar, evidence-based textbooks
– Panduan dari organisasi profesi, direktorat tertentu
Kemenkes dll [Usul nama: Panduan Umum PPK]
– Kesepakatan profesional
Clinical pathways
Merupakan bagian atau pelengkap PPK karenanya
memiliki karakteristik PPK termasuk:
– Hospital specific
– Merujuk PNPK atau sumber pustaka lain
Terbaik untuk penyakit / kondisi yang perlu penanganan
multidisiplin, dan perjalanan klinisnya predictable
Jangan dipaksakan, hindarkan“mentalitas menerabas”
Tidak menggantikan clinical judgment
Harus patient oriented, jangan sampai DRG-oriented atau
length of stay oriented
If you are not
confused,
you are not wellinformed
Thank you