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Guidelines in Chemotherapy

Djumhana Atmakusuma
Dharmais Cancer Hospital
Evidence base medicine:
Guidelines - level of evidence
- grade of recommendation

Evidence base medicine 


Consensus modified (plus local
considerations +
experiences ?)

Standard
operating
Must be done (mandatory)
procedures
(SOP)

Protocols
Guidelines

Consensus
Clinical Pathway
Standard
operating
procedures
(SOP)

Protocols
Guidelines
• A medical guideline (also called a clinical
guideline, clinical protocol or clinical practice
guideline) is a document with the aim of guiding
decisions and criteria regarding diagnosis,
management, and treatment in specific areas of
healthcare. Such documents have been in use
for thousands of years during the entire history
of medicine. However, in contrast to previous
approaches, which were often based on tradition
or authority, modern medical guidelines are
based on an examination of current evidence
within the paradigm of evidence-based
medicine. They usually include summarized
consensus statements, but unlike the latter, they
also address practical issues.
• Modern clinical guidelines briefly identify,
summarize and evaluate the best evidence and
most current data about prevention, diagnosis,
prognosis, therapy including dosage of
medications, risk/benefit and cost-effectiveness.
Then they define the most important questions
related to clinical practice and identify all
possible decision options and their outcomes.
Some guidelines contain decision or
computation algorithms to be followed. Thus,
they integrate the identified decision points and
respective courses of action to the clinical
judgment and experience of practitioners. Many
• Additional objectives of clinical guidelines
are to standardize medical care, to raise
quality of care, to reduce several kinds of
risk (to the patient, to the healthcare
provider, to medical insurers and health
plans) and to achieve the best balance
between cost and medical parameters
such as effectiveness, specificity,
sensitivity, resolutiveness, etc. It has been
demonstrated repeatedly that the use of
guidelines by healthcare providers such as
hospitals is an effective way of achieving
the objectives listed above, although they
are not the only ones.
GRADE OF CLARITY OF
METHODOLOGIC IMPLICATIONS
RECOMMENDATION RISK/BENEFIT
STRENGTH OF
SUPPORTING EVIDENCE

1. Risk / Benefit: A. Randomized controlled trials


CLEAR
(RCTs) without important limitations
2. Risk / Benefit: B. RCTs with important limitations
UNCLEAR
C+: No RTCs
C: Observational studies
• 1A : 1. Risk/benefit: Clear
A. Randomized controlled trials (RCTs) without important
limitations
Implications: Strong recommendation; can apply to most
patients, in most circumstances,
without reservation
• 1B: 1. Risk/benefit: clear
B. RCTs with important limitations (inconsistent results,
methodologic flaws*)
Implications: Strong recommendation; likely to apply to
most patients
• 1C+ : 1. Risk/benefit clear
C+. No RCTs, but RCT results can be unequivocally
extrapolated; or, overwhelming evidence from
observational studies
Implications: Strong recommendation; can apply to most
patients, in mostcircumstances
• 1C: 1. Risk/benefit: clear
C. Observational studies
Implications: Intermediate-strength recommendation; may
change when stronger evidence available
• 2A : 2. Risk/benefit: Unclear
A. RCTs without important limitations
Implic. : Intermediate-strength recommendation; best
action may differ, depending on circumstances or
patients’ or societal values
• 2B: 2. Risk/benefit: Unclear
B. RCTs with important limitations (inconsistent results
methodologic flaws)
Implic. : Weak recommendation; alternative approaches,
likely to be better for some patients under
some circumstances
• 2C: 2. Risk/benefit: Unclear
C. Observational studies
Implic. : Very weak recommendation; other alternatives
may be equally reasonable

* Such situations include RCTs with lack of blinding, and


subjective outcomes, in which the risk of bias in measurement
of outcomes is high; and RCTs with large loss to follow-up.
Consensus
• Consensus has two common meanings.
One is a general agreement among the
members of a given group or community,
each of which exercises some discretion in
decision making and follow-up action. The
other is as a theory and practice of getting
such agreements (for information on the
practice of achieving formal consensus,
see consensus decision-making).
• Achieving consensus requires serious treatment
of every group member's considered opinion.
Once a decision is made it is important to trust in
members' discretion in follow-up action. In the
ideal case, those who wish to take up some
action want to hear those who oppose it,
because they count on the fact that the ensuing
debate will improve the consensus. In theory,
action without resolution of considered
opposition will be rare and done with atte
Standard Operating Procedure
(SOP)
• The terms standard operating
procedure and standing operating
procedure, both abbreviated as SOP, are
used in a variety of different contexts:
healthcare, education, industry, military,
etc
• A standard operating procedure is a set of
instructions having the force of a directive,
covering those features of operations that lend
themselves to a definite or standardized
procedure without loss of effectiveness.
Standard Operating Policies and Procedures
can be effective catalysts to drive performance
improvement and improving organizational
results. [1] Every good quality system is based
on its standard operating procedures (SOPs).
• Protocols ??
Clinical Pathway
CLINICAL PATHWAYS

Multidisciplinary plans (or blue print


for a plan of care) of best clinical
practice for specified groups of
patients with particular diagnosis
that aid in the coordination &
delivery of high quality of care.

Dr Amrizal Muhammad Nur


Clinical Pathway
• Clinical pathway:
- Management & clinical audit tools
- Began with admission & ended with
discharge  (“Predictable”)
- Interdiscipinary in focus
- Merging the medical & nursing plans
of care with other disciplines (e.g;
physiotherapy, nutrition, mental health
etc) Dr Amrizal Muhammad Nur
Episode Model with Stages
and Clinical Activities
Clinical Events

Problem Diagnosis Therapy Follow Up


DBC End
Start

1 1 2 3 4 5
STAGES
Intake Diagnosis Pre Therapy Therapy Follow up

Activities Activities Activities Activities Activities


Dr Amrizal Muhammad Nur
Management of Acute Leukemia
Maintenance
Therapy
(> 2 years)
Follow-
Initial Phase Induction Consolidation up
Therapy Therapy
(> 1,2,5 yrs)
- Diagnosis - Pre-induction - Consolidation Hemopoietic
MIC (cytology, tests: focal chemotherapy: Stem Cell /
flowcytometry, infections,organ/ - AML: D3C7 Bone Marrow
cytogentics) system - ALL: LALA 87
Transplant-
- Treatment of abnormalities
complications - Induction Treatment of ation
chemotherapy: complications of (weeks,
(1 day–1 week) - AML: D3C7 chemotherapy months, years)
- ALL: LALA 87
(> 1 month) Relaps:
Treatment of
complications of Treatment
chemotherapy

(> 1 month)
How to develop Consensus & Clinical
Pathway in Dharmais Cancer Hospital
Cancer Working Groups
13 cancer working groups (from 28 medical staff group)
• Gynelogical cancer (cervix, ovarium, korpus uteri)
• Breast cancer
• Nasopharyngeal cancer
• Blood cancers
• Lung cancer
• GIT & hepatic cancer
• Urogenital cancer
• Head & neck cancer
• Musculosceletal cancer
• Skin cancer
• Brain cancer
• Pediatric cance
• Ophthalmologic cancer
Guidelines  Consensus
• Revision/Development: August 2005-August 2007
(2 yrs) : - 13 Tim Cancer Working Groups
- 54 cancers  82 consensus
• Format: - NCCN  algorithm & manuscript
- Algorithm NCCN = clinical pathway
 diagnosis, treatment, follow-up,
complication, co-morbidities
• Problems: difficulties in achieving consensus
among member of the team in terms of D/, Th/
and follow up ( many references: NCCN, ICN,
ASCO, ECCO, ESMO, cancer working groups)
Management of Acute Leukemia
Guideline of the Management of Acute Leukemia:
NCCN, NCI (USA)–Working Group (Europe, others)
 evidence base medicine (EBM):
grade of recommendation - level of evidence

National Consensus
on the Management of Acute Leukemia

Self Experience

Hospital Consensus: Essential Care


Best Clinical Practice Package = PPE
Clinical Pathway of “ Best Clinical Practice”
and “Essential Care Package (PPE)”

Hospital Consensus: Best Clinical Practice

Hospital Consensus
Best Clinical Practice Revision of Essential
+ Nursing SOP + Care Package = PPE
Nutrition SOP, others

Clinical Pathway Clinical Pathway


of “Best clinical of PPE
practice”
Clinical Pathway of Acute Myeloblastic
Leukemia (Outpatient or Inpatient Settings)
• CP 1: Diagnosis of Acute Myeloblastic Leukemia
• CP 2: Initial Treatment of Complications
of Acute Myeloblastic Leukemia
• CP 3: Pre-induction Tests
• CP 4: Induction Chemotherapy (CP 4 a, CP 4 b, CP 4 c, etc)
• CP 5: Consolidation Chemotherapy (CP 5 a, CP 5 b, CP 5 c, etc)
• CP 6: Maintenance Chemotherapy (CP 6 a, CP 6 b, CP 6 c, etc)
• CP 7: Treatment of Complications of the Treatment
• CP 8: Follow up of Acute Myelogenous Leukemia (CP 8)
• CP 9: Bone Marrow Transplantation (CP 9 a Autologous BMT,
CP 9 b Allogeneic BMT)
• CP 10: Peripheral Blood Stem Cell Transplantation (CP 10 a
Autologous PBSCT, CP 10 b Allogeneic PBSCT)
CP 1 (Best Clinical Practice): Acute Myeloblastic Leukemia: - ICD 10: C 95.0
Diagnostic Procedures of AM: - ICD 9-CM:

Intervention Visit/Day 1 Visit/Day 2 Visit/Day 3 Visit/Day 4 Visit/Day 5


Admission :
Assessment Demographic data
& other information
- Hematologists- Clin. Pathologists 
Consultation Med. Oncologists information the result to
& Nursing - Clin. Pathologist HOM (Rp ?)

Care
Diagnostic / - Bone marrow
aspiration/ biopsy
procedures - Peripheral blood
aspiration (Rp ?)
- Cytology,Cytoche - Results of Lab tests: Result of Lab tests: - Results of Lab tests: - Results of Lab tests:
Laboratory mistry, flowcytome cytology, Flow cytometry Histology of BMB Cytogenetics & DNA
tests try, Cytogenetics,
DNA analysis
cytochemistry, CBC,
blood smear,
plus imprint cytology analysis

- CBC,blood smear, hemostasis


hemostasis (Rp
-Paracetamol
Medications / -Free diet *Rp ?)
Nutrition
- Information (oral Results cytology/che- - Final result is inform
Information / / written) mistry & flowcytome- ed to a patient
Education - Informed consent try & th/ are informed
to a patient
- Final treatment is
inform- ed to a patient
- A patient accepts - Diagnosis of AML - Diagnosis of AML - Diagnosis of AML - Diagnosis of AML
Outcome BMA/BMB (cyto-logy/-chemistry) (immunoctochemistry (histology BMB & (cytogenetics & DNA
- No complications are finished / flowcytometry) is imprint cytology) are analysis are finished
finished finished

Varians
Persons in charge: Doctor I: Doctor II: Nurse:
CP 3 (Best Clinical Practice): Acute Myeloblastic Leukemia: - ICD 10: C 95.0
Pre – induction tests: - ICD 9-CM:

Intervention Visit/Day 1 Visit/Day 2 Visit/Day 3 Visit/Day 4 Visit/Day 5


Admission - Admission - Admission - Admission - Admission
Assessment Demographic data
& other information
- Hematologist- - Cardiologist - Dentist (result of - HMO
Consultation Medical Oncologist panoramic x-ray)
- Dentist
- ENT specialist
- X – ray: Chest , -EC - Teeth extraction - Teeth extraction
Diagnostic / teeth panoramic -Echocardiography
procedures
-CBC, LFT, kidney - Results of Lab tests: - Results of cultures
Laboratory function, blood all laboratory tests, are finished
tests sugar, uric acid
- Cultures (throat,
except cultures

urine, stool, blood)


- Hepatitis B,C, HIV
- Free diet - Treatment of focal - Treatment of focal - Treatment of focal
Medications / infection infection infection
Nutrition
- Information (oral HMO: information:
Information / / written) - results of diagnosis
Education - Informed consent & treatment
- induction therapy
- A patient accepts No abnormalities - All abnormalities (+
Outcome all activities infections) disappear
- No complications - A patient is ready for
induction therapy

Varians
Persons in charge: Doctor I: Doctor II: Nurse:
CP 4.a. (Best Clinical Practice): Acute Myeloblastic Leukemia: ICD 10:C 95.0
Induction chemotherapy  “D3C7 regimen”: - ICD 9-CM: 39.35

Intervention Day 1 Day 2 Day 3 Day 4 Day 5


Admission Nurses assessment Nurses assessment Nurses assessment Nurses assessment
Assessment Demographic data
& other information
- Hematologist- Visit HMO Visit HMO Visit HMO Visit HMO
Consultation Medical Oncologist Visit doctor in charge Visit doctor in charge Visit doctor in charge Visit doctor in charge
ECG, if necessary
Diagnostic / Chest X-ray if
procedures necessary

-CBC, LFT, kidney CBC CBC CBC, LFT,KF,BS CBC


Laboratory function, blood
tests sugar, uric acid
- Cultures (weekly)
-Oral & parentheral -Pre medications -Pre medications -Pre medications -Pre medications
Medications / -Pre medications -Day 2. Chemotherapy -Day 3 Chemotherapy - Day 4 Chemotherapy -Day 5 Cehmotherapy
Nutrition -D1 Chemotherapy
- See protocols
- Information (oral - Daily information: - Daily information: - Daily information: - Daily information:
Information / / written) a today program a today program a today program a today program
Education - Informed consent response & adverse
reactions
response & adverse
reactions
response & adverse
reactions
response & adverse
reactions
- A patient is ready No adverse events of No adverse evets of No adverse evets of - Daily information:
Outcome and suitable for the chemotherapy chemotherapy chemotherapy a today program
induction response & adverse
cheotherapy reactions

Varians

Persons in charge: Doctor I: Doctor II: Nurse:


CP 4.a. (Best Clinical Practice): Acute Myeloblastic Leukemia: ICD 10:C 95.0
Induction chemotherapy “ D3C7 regimen”: - ICD 9-CM: 39.35

Intervention Day 6 Day 7 Week 2 Week 3 Week 4


Nurses assessment Nurses assessment Nurses assessment Nurses assessment Nurses assessment
Assessment
Visit HMO Visit HMO Visit HMO Visit HMO Visit HMO
Consultation Visit doctor in Visit doctor in charge Visit doctor in charge Visit doctor in charge Visit doctor in charge
charge
ECG, if necessary ECG weekly ECG weekly ECG weekly
Diagnostic / Chest x ray if neces Chest x ray if necess Chest x ray if necess Chest x ray if necess
procedures Bone Marrow Aspirat.

-CBC CBC, LFT, KF,BS, CBC CBC, LFT,KF,BS CBC , bone marrow
Laboratory cultures cytology-chemistry,
tests flow cytometry,DNA

-Oral & parentheral -Pre medications - Antiemetics drugs - Antiemetics drugs - Antiemetics drugs
Medications / -Pre medications -Day 7 Chemotherapy - Supportive drugs - Supportive drugs - Supportive drugs
Nutrition -D6 Chemotherapy - Blood transfusions - Blood transfusions - Blood transfusions
- See protocols
- Information (oral - Daily information: - Daily information: - Daily information: - Daily information:
Information / / written) a today program a today program a today program a today program
Education - Informed consent response & adverse
reactions
response & adverse
reactions
response & adverse
reactions
response & adverse
reactions
- A patient is ready No adverse events of No adverse evets of No adverse evets of - Daily information:
Outcome and suitable for the chemotherapy chemotherapy chemotherapy a today program
induction response & adverse
cheotherapy reactions

Varians

Persons in charge: Doctor I: Doctor II: Nurse:


Conclusion
Evidence base medicine:
Guidelines - level of evidence
- grade of recommendation

Evidence base medicine 


Consensus modified (plus local
considerations +
experiences ?)

Standard
operating
Must be done (mandatory)
procedures
(SOP)

Protocols
Guidelines

Consensus
Clinical Pathway
Standard
operating
procedures
(SOP)

Protocols
• Indonesia ?? Guidelines ???