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 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

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 Physician’s proficiency Evidence Patient’s preference

The EBM Paradigm Health care problem Formulate Recom- in answerable question Recom- mendation Critically appraise the evidence 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 Algorithms Protocols Procedures Standing orders. Please note that there is no “standard” term at the level of healthcare facilities

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.pdf American Academy of Pediatrics. Clinical Practice Guideline: Diagnosis and Evaluation of the Child With Attention-Deficit/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:

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), 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.

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 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

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

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.

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.

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.

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

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

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)

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 well-informed Thank you