DEVELOPING

THERAPEUTIC
GUIDELINES

NITHIN MANOHAR R
M.Pharm,(PhD),MSc Psychology,
Assoc. Professor
Dept Of Pharmacy Practice
Pushpagiri College Of Pharmacy
Introduction
• 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.
 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.
This is especially important in developing countries,
where available funding sources for the healthcare system
are often insufficient and conflict of interest exist due to
ownership of equipment by healthcare providers.
• Lastly guidelines are necessary to increase consistency of
recommendations and treatment by practitioners.
Examples of guidelines
• The Sixth Report of the Joint National Committee on
Prevention, Detection, Evaluation and Treatment of High
Blood Pressure was developed by an executive committee,
multidisciplinary healthcare team representing the fields of
medicine, nursing, nutrition, pharmacy, public health and
staff at the National Heart, Lung and Blood Institute.
• The first guidelines to be formulated by an expert body of
Indian doctors were hypertension guidelines endorsed
jointly by the Cardiology Society of India, the
Hypertension Society of India, the Indian College of
Physicians and the Association of Physicians of India in
2001.
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.
1. Identify group members for guideline development.
• When developing the recommendations in the guideline, it is
always advisable to have a multidisciplinary groups.
• The ideal number of people involved in such a group is at
least 6 but no more than 15 members; too few members
limits adequate discussion and too many members makes
effective functioning of the team difficult.
• The choice of medical specialists in the development group
depends on the drug or disease being targeted.
• Healthcare professionals (up to five general practitioners, up
to two hospital consultants, a healthy authority medical
adviser, and a pharmacist); specialists (an epidemiologist and
a health economist); and a specialist in guideline
methodology and in leading small groups.
2. Identify & refine the problem focusing on the disease and
published literature.
• Guidelines can be developed for a wide range of subjects.
• Potential area can be identified based on the major causes of
morbidity and mortality for a given population, uncertainty about
the appropriateness of drug therapy or about the evidence for
improving patient outcomes.
• For example, the first step for preparing a treatment guideline in a
hospital is to select a drug/disease for guideline development and
then analyse the utilisation trends of the drug in the hospital to
assess the significance of the selection.
• After identification of the topic for guideline development, it has to
be refined before the evidence can be assessed in order to answer
exact questions. The usual way of refining a topic is by having a
dialogue among the potential users or evaluators of the guideline.
3. Review the literature, organisational recommendations
& internet resources to determine the present standard
of care.
• Identification & assessment of the evidence is best done by
performance of a systematic review. The purpose of a
systematic review is to collect all available evidences, assess
its potential applicability to the clinical question under
consideration, inspect the evidence for susceptibility to bias,
and extract and summarise the findings.
• Methods of identifying and synthesising evidence include
expert opinion, unsystematic literature review, graded
systematic review, and formal meta-analysis.
• To ensure validity and reliability. The guidelines should be
based on high quality research studies.
4. 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.
5. 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 .
6. 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.
• Therefore, the most attractive way for a local group to
develop a guideline is to adapt published guidelines for local
use.
7. Access the quality, relevance, variability and strength
of the information
• Summarized evidence is categorised to reflect its
susceptibility to bias.
• This is a shorthand method of conveying specific aspects of
the evidence to a reader of the guideline.
8. 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.
9. 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.
 Factors affecting implementation of guideline or
potential limitations of guidelines.
• Although most guidelines are useful tools to provide the busy
clinician with up-to-date information, physicians may regard
guidelines to be unrealistic, and some may even consider guidelines
to be a challenge to their autonomy.
a) 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. It is important therefore for guideline developers to take
into account the complexity of the guidelines. Particularly for
developers of multi-disciplinary guidelines directed at several target
groups with varying educational levels and backgrounds (e.g.
physicians, nurses, patients), it is a challenge to describe
recommendations that are understandable and usable for all target
b) 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.
c) 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, that explain that most
individual doctors may not agree with guidelines issued by
their own peers, leading them to choose a different course of
treatment, however, many doctors have seen that a specific
guideline may be too rigid to apply.
• 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.
d) 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.
 Important questions

1. Therapeutic guidelines and discuss briefly the factors

affecting its implementation. (5)