Developing therapeutic guidelines

DEVELOPING THERAPEUTIC
GUIDELINES
IRENE.V.R
M PHARM (FIRST YEAR)
DEPT OF PHARMACY PRACTICE
GRACE COLLEGE OF PHARMACY
1

Introduction
DEFINITION
Therapeutic Guidelines are clinical practice based
guidelines written principally for prescribers (general
practitioners and trainee physicians in particular) to
provide clear, practical and up-to-date therapeutic
information, for the management of patients with
specific conditions.
2

• Therapeutic guidelines focus on treatment recommendations
• Practice guidelines are systematically developed statements to
assist practitioners in choosing appropriate means for
diagnosis, monitoring and/ or treatment based on
predetermined clinical circumstances.
• Guidelines published in booklet format and distributed to
medical staff throughout the hospital.
• These guidelines can be used separately or together to provide
comprehensive care based on the patient’s disease state
3

The need for guidelines :
• The government agencies and professional organisations
have focused on improving the quality of patient care
through the quality of establishment of therapeutic
guidelines.
• Guidelines are also necessary to control healthcare costs
• Lastly guidelines are necessary to increase consistency of
recommendations and treatment by practitioners.
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⚫ Allows the practitioners to access the efficacy and
effectiveness of therapy, support and quantify patient
outcomes.
⚫ Assist practitioners in establishing monitoring
parameters to access the health status and quality of
life
⚫ Utilisation of published clinical guidelines allows
practitioners to incorporate international research data
into general practice and ensures that the standard
of care is provided to all patients without the costs
associated with individual practitioner investigation,
clinical trials, bias and error.

• Organisations such as AMA (american medical
association) and American academy of Pediatrics (AAP)
have played an active role in the establishment of
guidelines for the identification, quantification and
treatment of a variety of disease states
• In developed countries, guidelines decrease costs
through standardisation of care.
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Composition/ requirements
THERAPEUTIC GUIDELINES :
 Administrators (3 members)
 Medical & pharmacy Editors (6 members)
 One person from IT (Information technology)
 Researcher (1 person)
 Evaluators
 Marketer (1 person )
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Development of guidelines
• Steps in guideline development includes:
1. Identify group members for guideline development.
2. Identify & refine the problem focusing on the disease and published literature.
3. Review the literature, organisational recommendations & internet resources to
determine the present standard of care.
4. Obtain opinions from experts in the field.
5. Begin the information feedback process.
6. Coordinate resources to avoid duplication of resources and time.
7. Access the quality, relevance, variability and strength of the information.
8. Synthesise the information.
9. Summarise and disseminate the information, focussing on measurable outcomes.
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1.Identify group members for guideline development :
 Many investigators have written/or published clinical
practice guidelines.
 It is always advisable to have a multidisciplinary group as
individual biases may be better balanced by such
groups and may produce more valid guidelines.
 People involved in a group- 6 but not more than 12-
15.
 Three broad classes of relevant health professionals
 General practitioners (up to 5)
 Two hospital consultants ( up to 2)
 A health authority medical advisor and pharmacist.

 Specialists (an epidemiologists and a health
economist)
 A specialist in guideline methodology
• The guideline development groups are intended to define
important clinical questions, produce search criteria, draw
up protocols for systematic review.
• Members must have skill in sufficient areas such as
 Literature searching
 Epidemiology
 Biostatistics
 Health sciences research
 Writing
 editing

Identify and refine the problem focusing on the
disease and published literature
⚫Developed for a wide range of subjects.
⚫Given a large number of potential areas, priority subjects
or topics for guideline development need to be
determined.
⚫Potential areas can be identified based on the main
causes of morbidity and mortality for a given population.
⚫Uncertainty about the appropriateness of drug therapy
⚫Evidence for improving outcomes.
⚫Need for conserving human resources in in
providing care.

Review the literature, organisational
recommendation and internet sources to
determine the present standard of care:
⚫Identification and the assessment of the
evidence – performing a systematic review.
⚫The purpose of this collect
all available evidence,
review- to
assess its
potential applicability to the clinical question
under consideration, inspect the evidence for
susceptibility to bias and extract and
summarize the findings.

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 Checking the reference in articles will show additional
relevant articles not identified by the computer search, and
having experts in the field examine the list of articles helps to
ensure there are no obvious omissions.
The first step in gathering the evidence is to check if a
suitable, recent systematic review has already been
published

⚫Once studies have been identified, they have
been assessed for relevance to the clinical
questions of interest and for bias.
⚫Screening for relevance –abstract
⚫To ensure validity and reliability, the guidelines should
be based on high-quality research studies.
⚫Identified during comprehensive literature review
conducted within the recent past.
⚫This may be 12 months for areas where the evidence
has rapidly changed, but longer periods of time say
24-36 months, may be acceptable where new
evidence is produced more slowly.
⚫Data is extracted from the relevant studies on the
benefits, harm and costs of the interventions being
considered

Obtain opinions from experts in the field
• Opinions of experts should be used to interpret evidence
and to derive recommendations in the absence of evidence.
• Recommendations based solely on clinical judgment and
experiences are likely to be more susceptible to bias and
self-interest. Therefore, after deciding what role an expert
opinion is to play, the next step is deciding how to collect
and assess the expert opinion.
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Begin the information feedback process
• Information feedback refers to the provision of health data
information which may allow clinicians to compare their
own practice with the practice of their colleagues or other
hospitals.
Coordinate resources to avoid duplication of resources
and time
• Judgments about whether the costs of tests or
treatments are reasonable depend on how cost
effectiveness is defined and calculated, and on the resource
constraints of the healthcare system.
• Comparative studies conclude that internal guidelines are
less likely to be scientifically valid because local groups
require greater resources and lack the clinical, managerial
and technical skills, needed to develop guidelines.
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• Therefore, the most attractive way for a local group to
develop a guideline is to adapt published guidelines for local
use.
Access the quality, relevance, variability and strength of
the information
• Summarized evidence is categorised to reflect its
susceptibility to bias.
• This is a shorten method of conveying specific aspects of the
evidence to a reader of the guideline.
Synthesise the information
• Synthesis of study results is the most subjective area of
guideline developments and impacts on the presentation,
acceptability and dissemination of results.
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Summarise and disseminate the information, focussing on
measurable outcomes
• The way in which guideline is presented will determine how
well it is accepted.
• Guidelines can be presented as the full version, summary
sheets of all or part of the guideline, or reminder sheets
in patient records.
• ‘Plan, do, study, act’ cycle is necessary to determine the
effect of practice guidelines and to close the gap between
practice and treatment.
• Evaluation of the failures in the present system is important
to improve practitioner acceptance ad utilisation.
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Factors affecting implementation of guideline or
potential limitations of guidelines.
• Complexity
Studies indicated that when a guideline can be relatively
easily understood and tried out, the chance is greater that
the guideline will be used.
• Organizational and resource related factors
• Effective organizational structure with strong leadership and
a powerful learning culture were found to be important
facilitating factors in implementing guidelines.
• Lack of financial resources was also raised as an essential
issue that prevents the progress of implementation work
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Physicians related factors
Studies found that knowledge, attitude and behaviour are
considered the main factors that affect physicians’ adherence.
Knowledge: Knowledge such as lack of familiarity and
awareness, volume overload, time needed to stay informed
and guideline accessibility are important in modifying
physician practice patterns.
Attitude: Physician attitude about practice guideline is
another barrier to guideline adherence. Lack of agreement and
confidence with specific guidelines
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• Therapeutic guidelines are useful only when the prescribers
are not clear about appropriate practice or evidence-based
practice. Guidelines may not be useful when the
practitioners are aware of the information contained in it.
Characteristics of patients
• Characteristics of patients, too, appear to exert influence:
for instance, co-morbidity in a patient appears to reduce the
chance that guidelines are followed.
Other limitations include:
• The guidelines were too time-consuming.
• Too cumbersome
• Difficult to understand and/or did not leave room for
personal experience and clinical judgment. Physicians
preferred review articles compared to guidelines.
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Reference
1. Ramesh K.Goyal. A textbook of Hospital pharmacy;34-
40
2. Alexis Ogdie , Laura C, Coates and Dafna D. Gladman.
Treatment guidelines in psoriatic arthritis ;2020
3. Tausch, B. D. (2001). Perceived effectiveness of
diagnostic and therapeutic guidelines in primary care
quality circles. International Journal for Quality in Health
Care, , 239–246.
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