1. Clinical Practice Guidelines
Sudigdo Sastroasmoro Konsorsium Upaya Kesehartan Ditjen BUK Kemenkes RI

2. 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

3. 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."

4. Patient safety Clinical audits EBM: # HTA # Clinical guidelines
Governance
audits
Education
& Training
Risk
management
Account-
ability
Research &
development
Effective-
ness
Clinical audits
EBM:
# HTA
# Clinical guidelines
# Clin pathways
# Algorithms
# Protocols
# Procedures
#Standing orders

5. 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

6. “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)

7. EBM Practice
Physician’s proficiency
Evidence
Patient’s preference

8. The EBM Paradigm Health care problem Formulate Recom- in answerable
question
Recom-
mendation
Critically
appraise
the evidence
Search the
evidence

9. Taxonomy of health system standards (Ashton, 2002)
Clinical practice guidelines
Clinical pathways
Protocols
Procedures
Algorithms
Standing orders
Must be:
# Evidence-based
# Periodically
revised

10. 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.

11. Juliet Capulet: What’s in a name? A rose by any other name
would smell as sweet
The Merchant of Venice – W. Shakespeare

12. 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
Algorithms
Protocols
Procedures
Standing orders.
Please note that
there is no “standard”
term at the level
of healthcare
facilities

13. 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

14. 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) .

15. 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

16. 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).

17. 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

18. 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

19. 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

20. 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 s
Monthly meetings
Completed after 2-4 meetings
Director General / MOH

21. 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

22. 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

23. 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).
American Academy of Pediatrics. Clinical Practice Guideline: Diagnosis and Evaluation of the Child With Attention-Deficit/Hyperactivity Disorder. 13 halaman, 60 rujukan.
Guideline for Alzheimer’s Disease Management. Final Report Supported by the State of California, Department of Public Health. California Version © April halaman plus apendiks, total 122 halaman, lebih dari 300 rujukan.

24. ACC/AHA 2008 Guidelines for the Management of Adults With Congenital Heart Disease: Executive Summary. 49 halaman, 202 rujukan.
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, halaman, 33 rujukan.
Malaysian Society of Neurosciences, Academy of Medicine Malaysia, Ministry of Health Malaysia. Clinical practice guidline. Management of stroke. 37 halaman, 150 rujukan.
Indeks untuk pelbagai jenis CPG di Malaysia dapat diakses melalui
Singapore MOH Clinical Practice Guideline Management of atrial fibrillation. 70 halaman total, 83 rujukan.

34. 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.

35. 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

36. 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

37. 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.

38. 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

39. 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:

40. 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.

41. 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

42. 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

43. 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), case-based 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.

44. 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.

45. 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

46. 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

47. 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.

48. 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”.

49. 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.

50. 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

51. Disclaimer PPK is developed for average patients
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

52. Applying guidelines to the care of an individual patient
always requires judgment

53. 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

54. 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.

55. 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.

56. 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.

57. 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.

58. 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.

59. 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.

60. The cardinal rule in medical records:
If it isn’t written down,
it didn’t happen

61. Revisions of PPK Recent evidence Periodic revisions
Usually every 2 years
Use of intranet may save money

62. 3/17/10 62626262 Clinical Practice Guidelines Clinical Pathways
Algorithma
Procedures
Protocols
Standing Orders
3/17/10
J Ashton, 2002

63. Textbook, Professional Organization Guidelines, etc
Literature
Primary articles
Systematic reviews
Guidelines
Textbook, Professional Organization Guidelines, etc
Consensus
PNPK
Standard Operating Procedures = PPK
Can be developed
Without awaiting
PNPK
Pathways
Algoritms
Protocols
Prosedures
Standing orders
According to
Type and strata
(hospital specific)

64. 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)

65. 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

66. 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

67. 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

69. If you are not confused,
you are not well-informed
Thank you