Overview of

Clinical Practice Guideline

Development
Kim Carmela D. Co, RN, MSc
Department of Epidemiology and Biostatistics
College of Public Health, University of the Philippines Manila
Email: kimcarmelaco@up.edu.ph
Clinical Practice Guidelines
“Recommendations intended to optimize patient care that are
informed by a systematic review (SR) of evidence and an
assessment of the benefits and harms of alternative care options”
[IOM 2011, as cited in DOH (2018)]

• Goal of a CPG is to improve the quality of healthcare by

reducing inappropriate variations in practice and ensuring
more efficient use of limited resources
Formulating Clinical Questions
• For each topic, primary questions may be relatively broad and
amenable to having 2 or more secondary questions that are more
specific
• Each question, whether primary or secondary, may encompass a
single or multiple individual recommendations

• Should ideally be refined based on input from anticipated

end-users and stakeholder groups
Formulating Clinical Questions
Clear and focused questions Population (,problem)
will steer the evidence search
and guide the development of
recommendations. Intervention
Should be specified with
enough detail Comparisons

Outcomes
Defining the Scope of the Study

Advantages Disadvantages

Comprehensive Risk of too

Assessment of Requires more
Broad summary of much
generalizability resources
evidence heterogeneity

Clarity of
Manageability May have too Limited
Narrow review
for review team little studies generalizability
question
P Characteristics of the patient (e.g., Disease condition, age groups, sex, ethnicity, social
identities, behavioral characteristics, or other specific constraints)

Exposure (E) of interest (e.g. therapy, diagnostic test, risk factor, or preventive measure)
I Variations to consider (dosage, frequency, delivery or administration, personnel and
delivery channels, timing and duration, etc.)

C Alternative choices of action (e.g., placebo, no intervention, standard of care or gold

standard in diagnosis, or other variations of intervention)

O Measurable clinical/epidemiological/health outcomes relevant to the

intervention/population (e.g. Efficacy, effectiveness, safety, adverse events, compliance)
Nature of Clinical Questions
Among P (patients with a certain disease), how effective is
Therapy E (a certain treatment) in preventing O (an adverse
outcome)?

Among P (patients with a certain condition), how accurate

Diagnosis is E (a certain test), in diagnosing O (a disease)?

Among P (patients with a certain condition), by how

Harm much does E (a potentially harmful exposure), increase
the risk of O (an adverse outcome)?

Among P (patients with a certain disease) who have E

Prognosis (certain prognostic factors), what is the probability of O
(an outcome)?
Rating Outcomes
• Outcomes identified must
be evaluated and ranked
according to importance

• Scored from 1 to 9 with

increasing importance for
decision making
• “Important” and “critical”
outcomes will affect
guideline recommendations
GRADE Handbook, 2013
Clinical parameters to differentiate need for hospitalization

P
I
C
O
Among children with pneumonia, what is the probability of
severe pneumonia among those with high or low respiratory rate at
admission?
Getting the Evidence
Getting the Evidence for CPGs
Search for
existing CPGs

Search for
If with CPGs
existing SRs
Appraise the CPGs

Do a systematic
If with SRs
review
Appraise the SRs
Looking for Previous CPGs
• CPG development may not be necessary if there is an existing
international CPG on the same topic that can be modified to fit
the local setting
• Validity assessed using the AGREE II tool
• Validity primarily rests on the quality of the evidence that was reviewed
and considered in the recommendations

• Evidence summaries are adapted from the existing CPG, but

matched to the specific PICO questions
Looking for Previous SRs
• A systematic review of existing evidence from primary studies are
the main evidence base for CPGs
• However, this is a very time-consuming and resource-intensive activity

• Do a comprehensive literature search first for existing SRs

• If the literature search will yield published high-quality SRs
already available,
• Not mandatory to undertake a new SR
• Efforts can be directed to appraising the existing SR and updating it
accordingly
Literature Search
• Develop a search protocol based on the PICO question
• Should utilize multiple databases
• Should be duly documented
• Databases searched
• Date search was conducted
• Period searched
• Subject headings and keywords used
• Number of results retrieved
• Can be summarized in a PRISMA flowchart
PRISMA
Flowchart
Creating PRISMA flowcharts
http://prisma.thetacollaborative.ca/
Building the Search Strategy
1. Eligibility Criteria
2. Concept Building
3. Related terms
4. Field Tags
5. Controlled Vocabulary
6. Boolean operators
1. Eligibility Criteria
Set an inclusion/exclusion criteria at the start
• Research design
• Population studied or location of the study
• Date range of information

Limit restrictions to those that are really needed, as the goal is to

do a sensitive search.
1. Eligibility Criteria
Focus your results by using filters.

You can filter by a variety aspects:

• Publication date
• Language
• Age group
• Sex
• Animal vs human studies
• Article type (eg, review, case report)
• Search field (eg, title/abstract)
• And others
2. Concept Building
• Identify main concepts being examined in the review

Usually includes terms for:

Health condition Types of study

Exposure or
of interest design to be
Intervention
(i.e. population) included
3. Related Terms
• List down related terms for each of the concepts
Synonyms: Related terms: Variant spellings:
• Decubitus ulcer • Brain • Tumour OR Tumor
• Pressure sore • Head • Anemia OR Anaemia
• Bed sore • Cranial

Drug brand names Lay and medical Acronyms:

• Atorvastatin terminology: • AIDS
• Lipitor Cerebrovascular accident
Stroke
3. Related Terms
• Truncation:
random* (for random or randomised or randomized or
randomly);

• Exact phrases:
“breast cancer”
4. Field Tags
• Use field tags
• [ti] to search a title word

• The field tag must be enclosed in square brackets.

• Case and spacing do not matter (e.g., crabs [MH]= Crabs[mh])

• Example: diabetes [ti] searches for “diabetes” in the article title.

5. Controlled Vocabularies
• Dictionary of index terms used by a database
• Provides a way of retrieving articles that may use different words
to describe the same concept
• Provide information beyond that which is simply contained in the
words of the title and abstract
• Can be determined from identified relevant articles by noting
common terms used to index them

• MeSH (MEDLINE) and EMTREE (EMBASE)

• MeSH terms have a variety of subheadings that you can use to
focus your results more precisely

PubMed Search
6. Boolean Operators
OR
• Joining together each of the
related terms within each concept
• Expands the search
AND
• Combining the sets of terms
• Narrows the search
6. Boolean Operators
Combining AND and OR
(Smoking OR Nicotine) AND cancer
 To add this search Time when search
term again to the was conducted
current search

Order of terms Search terms used Number of articles

searched. Can just satisfying the search
type #1 to refer to terms. Can be clicked to
this search line see the list of articles.
Respiratory Rate (RR) as a prognostic factor
among children with pneumonia

Keywords RR Pneumonia

Lung Pulmonary
Related terms Breaths Ventilation Tachypnea
inflammation inflammation
Respiratory Rate (RR) as a prognostic factor
among children with pneumonia

Keywords RR Pneumonia

Lung Pulmonary
Related terms Breaths Ventilation Tachypnea
inflammation inflammation

“Respiratory
MeSH “Pneumonia”
Rate”
Search for Literature
Comprehensive Literature Search
• Search multiple databases
(Medline, EMBASE, Cochrane, PROSPERO)

• Look for grey literature (ProQuest, conference abstracts)

• Reference tracing
Screening Process
1. Remove duplicate journals (note number)

2. Title and Abstract Screening

• At least two people should screen

3. Full Text Screening

• Read full journals and collect study characteristics to determine if eligible
for inclusion
• Keep a record of why you reject each one
• At least two people should screen
Title and Abstract Screening
Possible Format of Summary of Decisions:
Citation P I C O M R1 R2 D
Citation details
Objectives of the included review
Type of review
Participant details
Intervention included
Comparator included
Outcomes included (highlight those in the current review question)
Study designs included
Number of databases sourced and searched
Date range of database searching
Publication date range of studies included in the review that inform each outcome of interest
Number of studies, types of studies and country of origin of studies included in each review
Instrument used to appraise the primary studies and the rating of their quality
Results of outcomes relevant to the umbrella review question
Method of synthesis/analysis employed to synthesize the evidence
Comments or notes the umbrella review authors may have regarding any included study

Decision (Include/Exclude):
Reason for exclusion (if excluded):
References
• Department of Health Philippines. 2018. Manual for Clinical
Practice Guideline Development.
• Higgins JPT, Green S (editors). Cochrane Handbook for
Systematic Reviews of Interventions Version 5.1.0 [updated March
2011]. The Cochrane Collaboration, 2011. Available from
www.cochrane-handbook.org.
• World Health Organization. (2014). WHO handbook for guideline
development, 2nd ed. World Health Organization.