BASIC APPROACHES IN CLINICAL PRACTICE GUIDELINE DEVELOPMENT

Melchor Victor G. Frias, IV, MD, MSc, FPPS

Limited scientific evidence

CLINICAL PRACTICE GUIDELINES (CPG)
Systematically developed statements to assist practitioner
and patient decisions about appropriate health care for
specific clinical circumstances.
US Institute of Medicine, 1990
Field & Lohr, 1990
Competing obligations inhibit clinicians from critically appraising
each modality. As doctors, we don’t have the luxury of time to read
many articles and studies regarding different clinical trials done
about various drugs, tests and diagnostic procedures. Clinical
practice guidelines help overwhelmed health practitioners cope with
the flood of new drugs and devices available to them by
summarizing all of these options (diagnostic or therapeutic). These
options are based on current information from expert opinion,
evidence from researches and scientific literature or from
experiences of different doctors or panels. CPGS do not only assist
the clinicians or health practitioners but also the patients in making
decisions as to what drugs or diagnostic modalities do they prefer.
Some CPGs will present algorithms in making a diagnosis and in the
management and treatment of a disease. Some could give the
etiology of the disease of a patient. But unfortunately, not all
diseases have a CPG.
 Review of previous studies is done to come up with
recommendations.
 Little evidence in the literature to support the claim or
recommendation of observation or antibiotic therapy
Recommendations on Myringotomy
With or without insertion of tympanostomy tube should not be
performed as initial management of otitis media, on the bases that:
1. Evidence suggests that otitis media with effusion resolves
spontaneously in most cases
2. There is a lack of conclusive evidence that a short period of
otitis media with effusion will have a deleterious effect on an
otherwise healthy child.
Each time there is a recommendation in a CPG, they would back it up
with evidence they have during the review.
Not recommended (As they are shown to not have any role in the
treatment of otitis media)
1. Steroid therapy
2. Antihistamine/ Decongestant therapy
3. Adenoidectomy
4. Tonsillectomy
CPG PROCESS

END GOALS OF CPG  Development

 Improve the quality of health care.  Dissemination
 Reduce the use of unnecessary, ineffective and harmful Disseminated to those who would implement it like different
interventions. specialists and physicians

 Facilitate the treatment of patients with maximum chance  Implementation

 Evaluation
of benefit with minimum risk of harm at an acceptable cost.
After 3-5 years, it is reviewed and re-evaluated. The panel is
then gathered and will look for new evidences.
Example of a CPG:
 Revision
Otitis Media with Effusion in Children Revise if there are additional changes. After revision, it will be
re-developed.
A physician is confronted with a child with ear discharge who then is
diagnosed to have otitis media. CPGs would tell you how to manage
the child with certain categories and classifications.
The whole CPG process is a cycle.
Treatment options: Observation vs. Antibiotic therapy

In most instances, the effusion ceases by itself (self-limiting). It is

usually not treated right away with antibiotics. But in some cases,
pediatricians almost always give antibiotics right away.

If the child is healthy, however, based on the evidence, the Development

pediatrician could just observe the patient with antibiotics as a side
option. This option is based on limited evidence and strong panel
consensus.

Panel consensus
Revision Dissemination
 CPG is done by a panel of experts to look for evidence of
treatment until a consensus is arrived at, which will become the
recommendation.

Panel members – are persons involved in developing the CPG. They

are usually multi-sectoral or multi-disciplinary. (It is better to have a
diverse group of panel members so that the recommendations will
be comprehensive and well-represented.) In this case, it may involve
specialists on infectious diseases, pediatricians, nurses or even
patients. There is usually an introduction that presents the list of
Evaluation Implementation
panel members.

 If there are environmental risk factors involved, the parents

should be encouraged to control them. (ex. eliminate stimuli for
allergic rhinitis which may initiate ear effusion)

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 GUIDELINE DEVELOPMENT
Disadvantages Disadvantages
Three Basic Approaches 1. Decibel factor 1. Time and cost constraints
 Evidence-based In a panel, some members 2. Difficulty of the process
 Consensus-based are quite vocal in insisting
 Evidence and Consensus-based that they are right. They
could influence the votes of
Woolf, SH, 1993 the other members.
Audet, AM, 1990
2. Difficulty in the
EVIDENCE-BASED APPROACH
assessment of the guides’
Utilizes a systematic synthesis and appraisal of the literature validity
and gives recommendations according to the strength of It’s hard to determine if the
evidence. panel members are really
qualified or are really experts
Subcommittee- are persons independent from the panel. Its in their respective fields.
function is to look for all the available evidences. (These
evidences may be electronic-based or hard copies. It also 3. Limitations to validity of
includes all the published and unpublished evidences.) They experts’ opinions
are responsible for appraising how rigorous the evidences Some statements are only
are gathered by the authors. The summary of their appraisal based on the opinion of a
are then submitted to the panel who will use this as basis particular person.
for their recommendations.
4. Dependence on
 Enhances scientific rigor personalities and affiliations.
Because it is based on scientific evidences There might be a conflict of
interest.
 Inability to produce recommendations in the absence of
acceptable evidence.
Main obstacle in this kind of approach.
GUIDELINE DEVELOPMENT CYCLE
Formal Consensus Building Technique
 Thorough and systematic literature search

 Critical appraisal or rigorous review of the literature (based

on a set of criteria) – strength of evidence: level and quality Problem
Assess the strength of evidence. Devise a grading system in identification
terms of level and quality
Schedue of
Panel Selection
Review
 Systematic synthesis of the literature
The subcommittee gives the panel a summary of evidences.

 Evidence-based report – recommendations based on

evidence are classified according to a system of rating and
grading. After the panel reviews the evidences given by the Final Draft Data Retrieval
subcommittee, they would put out an evidence based
report.

CONSENSUS-BASED APPROACH
Utilizes agreement or consensus building techniques to Exchange of
produce statements or recommendations Feedback Ideas, Definition
of Consensus

Informal consensus
building technique
Results in guidelines
reflecting the global
subjective judgement of the
“experts” who are framers
or developers of the CPG.
In this technique, the lead of the
panel will ask for the expert
opinions of the panel members.
Their recommendations or
statements would be based on
the majority or the consensus of
the panel.
Advantages
1. Easy
2. Fast
3. Free of complex analytical
procedures
Because it only involves getting
the decision of the majority
Formal consensus
building technique
Results in guidelines
reflecting the use of a
structured methodology in
consensus building
This type of approach is used
in the general steps in
guideline development.
See guideline dev’t cycle
Advantages
1. Validity can be measured
2. Personalities/affiliations
exert less influence
3. Evidence beyond experts’
opinions
4. Acceptance is almost
assured
Construction of
Draft
1. Problem Identification
2. Panel Selection
Panel should be multi-sectoral or multi-disciplinary.
3. Data Retrieval
Some panel would make use of a subcommittee who
would retrieve data or evidences regarding a particular
disease.
4. Exchange of Ideas, Definition of Consensus
Discussion of the different data gathered; Determination
of what builds up the consensus (ex. 90% of the panel)
5. Construction of Draft
6. Feedback
Presentation of the draft in a public forum
7. Final Draft
8. Schedule of Review

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SPECIFIC FORMAL CONSENSUS BUILDING TECHNIQUES
1. Nominal Group Technique
Most rigorous technique
 Provides for a structured meeting for obtaining information
 Equal participation among members
 Output is independent of personalities or affiliations
 Time constraints/reliance on skilled facilitators
Facilitator – should be knowledgeable and should be able to
control the panel adequately
Steps
1. Silent generation of ideas in writing
Panel members are not allowed to talk to each other. They will
write their opinion or recommendation regarding a particular
problem or issue.
2. Round robin recording of ideas
Facilitator would ask about what each panel member wrote.
These ideas are then recorded.
3. Serial discussion for clarification
4. Preliminary vote on item importance
Ideas are ranked according to their importance.
5. Discussion of the preliminary vote
Round robin discussion of the preliminary vote guided by the
facilitator.
6. Final vote
2. Delphi Technique
Used in surveys and if there is time & cost constraint issues
 Seeks consensus anonymously through self-administered
questionnaires
 Provides for easier access to many experts
This technique is not limited to a certain set of panel. You can
send questionnaires to different experts or personalities other
than those in the panel.
 Provides for impersonal expression of views
There is no discussion.
 Constrained by element of time
Because you have to wait for the feedback. Some may not even
return these questionnaires so you have to follow up.
 May become complicated and exhaust the panellists
After the results from the questionnaires are gathered, the
panel reviews them until they arrive at the consensus thus
enabling them to give statements or recommendations.
3. Vote by Mail
 Collect experts’ opinions by mail
Expert opinions are tallied. Consists of “yes” or “no” answers
 Easy and produces fast results
 Very little interaction among experts
 Simple voting rather than a true consensus is achieved
Vote on particular items in the questionnaire. No discussion.
Less rigorous than the first two techniques. Definition of
consensus in this technique is quite questionable.
Steps
1. Panelists are asked to rate specific indications for certain
diagnostic or therapeutic procedures.
2. Results are published in a journal.
4. “Science Court”
 Gathers all the panellists in a closed session to present and
discuss issues (“testimonies” regarding their experiences).
Consensus statements are produced after the meeting.
 Multi-sectoral approach
 Absence of explicit criteria for consensus and voting process
Least rigorous and least acceptable method
All techniques will have a multi-sectoral approach.
Most common specific formal consensus building technique
Nominal Group Technique and Delphi Technique
EVIDENCE-BASED AND CONSENSUS-BASED APPROACH
Utilizes consensus building techniques (formal consensus
building technique) in its methodology. In the resulting
document, distinction is made on recommendations based on
existing evidence and on experts’ opinions. Evidence are
classified according to a system of rating and grading
Makes use of the methodology in the consensus-based
approach and the system of rating and grading in the
evidence-based approach thus making it more rigorous.
LEVELS OF EVIDENCE FOR RATING STUDIES
ON THE EFFECTIVENESS OF TREATMENT*
An RCT that demonstrate a statistically significant
difference in at least one major outcome or if not
Level 1 statistically significant, an RCT of adequate sample
size to exclude 25% difference in Relative Risk
Ratio with 80% power
Level 2 An RCT that does not meet the level 1 criteria
A non-randomized trial with concurrent controls
Level 3
selected by some systematic method
Before-after study or case series (at least 10
Level 4 patients) with historical controls drawn from other
studies
Level 5 Case series (at least 10 patients) without controls
Case series (fewer than 10 patients) or case
Level 6
reports
* Any study that is based on evidence-based approach or on a
combination of evidence-based approach and consensus-based
approach should follow this table.
Levels of evidence for rating studies on:
1. Efficacy or effectiveness of treatment
2. Accuracy of diagnostic tests
3. Prognosis or causation
4. Review articles
LEVEL OF EVIDENCE (Rating)
Evidence for meta-analysis of randomized
Ia
controlled trials
Evidence from at least 1 randomized
Ib
controlled trial
Evidence from at least 1 controlled study
IIa
without randomization
Evidence from at least 1 other type of quasi-
IIb
experimental study
Evidence from non-experimental descriptive
III studies, such as comparative studies,
correlation studies and case-control studies
Evidence from expert committee reports or
IV opinions or clinical experience of respected
authorities, or both
This table is more rigorous in trying to classify the level of
evidence about a particular recommendation.
Meta-analysis – highest form of hierarchy of evidence, as it
synthesizes all the data and gives a single result.
STRENGTH OF RECOMMENDATION (Grading)
A Directly based on category I evidence
Directly based on category II evidence or
B extrapolated recommendation from category
I evidence
Directly based on category III evidence or
C extrapolated recommendation from category
I or II evidence
Directly based on category IV evidence or
D extrapolated recommendation from category
I, II or III evidence
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 GRADING SYSTEM FOR RECOMMENDATION Past-E questions
Batch 2016 & Batch 2018
The recommendation is based on one or
Grade A For nos. 36-43, choose the best answer:
more studies at level 1 A. Consensus-based
Grade B The best evidence available is at level 2 B. Evidence-based
Grade C The best evidence is at level 3 C. Both A & B
The best evidence available is lower than D. Neither A nor B
level 3 and included expert’s opinions, clinical 36. This approach to guideline development employs the method of
experience and common sense. These forming an accord among experts and categorization of
Grade D information in the literature into a classification of rating. C.
recommendations address practical issues of
37. This approach to guideline development employs a meticulous
implementation and other factors existing in appraisal, synthesis and/or assessment of the scientific literature and
the local setting. gives recommendations according to the strength of information. B.
38. This approach to guideline development employs a variety of
CPGs have different approaches for rating and grading. methods to form an accord among experts in order to generate
statements or recommendations. A.
39. This approach includes in its procedures the strategies for
dissemination, implementation and evaluation of the guideline. D.
Evidence-based approach, Consensus-based approach and the
Problem combination of these two approaches are approaches used in
identification guideline development.
40. This approach adds to the technical and scientific rigor of the
Schedue of guideline. B.
Panel Selection
Review 41. This approach uses techniques to build agreements however in
the resulting recommendations, distinction is made on statements
based on existing facts or substantiation of data and those based on
Consensus-based
experts’ opinions. C.
Evidence-based 42. This approach has the inability to generate recommendations in
 Literature search the absence of adequate proof or substantiation. B.
 Critical appraisal/ 43. This approach to guideline development produces guidelines
Final Draft Review of the literature Data Retrieval
indicating the use of an ordered methodology in generating accords
 Systematic synthesis of since it is used in the general steps in guideline development. A.
the literature
 Evidence-based draft
For nos. 44-50, choose from the following consensus building
methods:
A. Informal
Exchange of Ideas,
Feedback Definition of B. Formal
Consensus C. Both A & B
D. Neither A nor B
Penultimate Draft 44. Applying this consensus building method generates guidelines
demonstrating the largely all-inclusive individual views of experts
who are its framers. A.
45. Applying this consensus building method generates guidelines
The combined consensus-based and evidence-based approach demonstrating the use of a deliberated and organized procedure in
consensus building B.
utilizes the same steps as with formal consensus building
46. The “decibel factor” is a shortcoming linked with this consensus
techniques with an addition of heavier data retrieval to look building method. A.
for better evidence, resulting in the penultimate draft. It is 47. In this method, the soundness of the consensus can be assessed
more rigorous and more evidence-based process compared to and there is information outside of experts’ views. B.
either type standing alone. It usually uses the nominal type of 48. In this method, the consensus is based on evidence which are
formal consensus building. classified according to a system of rating and grading D.
This is only applicable for evidence-based approach. Informal and
formal consensus building techniques are under consensus-based
approach.
END OF TRANSCRIPTION 49. This consensus building method is simple, expeditious and
devoid of complicated methodical processes. A.
50. Makes use of structured and non-structured consensus
building methods to generate statements or recommendations. C.
“So let’s not get tired of doing what is good. At just the right time, Structured consensus building methods – formal
we will reap a harvest of blessing if we don’t give up.” Non-structured consensus building methods – informal
Galatians 6:9
For nos. 51-55, choose from the following consensus building
Transcription Team 2019 methods:
Transcribed by: Trisha Mae M. Bongcales A. Delphi technique
References: Lecture notes, PPT, B. Science court
Batch 2016 trans, Batch C. Vote by mail
2016-‘18 Past- Es D. Nominal group
Remarks: Less time to mourn 51. This consensus building method offers for a straightforward
contact to various authorities through the use of surveys and for a
More time to grind detached articulation of views. A.
#LABAN2019  52. This consensus building methods offers for an ordered meeting
for acquiring information with evenly balanced contribution among
experts guaranteeing an output free of personalities or affiliations. D.
53. In this consensus building method, consensus statements are
generated following a presentation and discussion of issues in an
assembly but there is no definite standard for determining a
consensus and no specific voting procedures. B.
54. This consensus building method obtains consensus among
unidentified experts through self-administered surveys. A.
55. This consensus building method is simple, generates prompt
results however there is not much communication among experts
and that a genuine consensus is not attained. C.

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