Guidelines �/ let’s take a break and then move forwardtogether!

Flemming Bro1 and Frans Boch Waldorff2

1Department of General Practice, Institute of Public Health, University of Southern Denmark, Odense and 2CentralResearch Unit and Department of General Practice, Institute of Public Health, University of Copenhagen, Copenhagen,Denmark.

Scand J Prim Health Care 2004;22:2�/5. ISSN 0281-3432

With our limited resources, the national colleges of general practice in

the Nordic countries should select only a few important topics and only

get involved in guideline preparations if they have a primary care

perspective. We need not develop our own guidelines from scratch, but

should take existing international GP clinical guidelines and literature

reviews as a starting point and conduct the first steps in the guideline

preparation jointly in the Nordic countries. More effort could then be

directed towards the subsequent stages of guideline preparations and

the implementation process. Key stakeholders should be involved at all

stages in guideline development and at all levels of the health services

to ensure commitment and improve the likelihood of implementation.

Key words: clinical guidelines, development, general practice, imple-

mentation.

Flemming Bro, Department of General Practice, Institute of Public

Health, University of Southern Denmark, Winsløwparken 19, DK-

5000 Odense C, Denmark. E-mail: fbro@health.sdu.dk

Clinical guidelines are defined as: Systematically

developed statements designed to assist in decision-

making about appropriate health care for specific

clinical conditions (1). The guideline concept has

gained international support from many sides, includ-

ing the Nordic countries.

In this article we discuss why clinical guidelines are

developed and suggest how Nordic general practi-

tioners (GPs) should deal with them in the future.

Good and bad reasons for developing a clinical guideline

As individual GPs, we have all compiled our own

selection of notes with rules of thumb on how to

diagnose and treat different conditions, notes which

we find useful or at least did when we first wrote them

down. Such individualised clinical guidelines havealways existed and represent an attempt by the

individual to bring about some order in a chaotic

clinical world. For the practice as an organisation, a

written guideline can be an attempt to ensure the

quality of that organisation’s activities. However, what

finds its way into the personal notes of the GP or the

‘‘book of procedures’’ in the practice will be random

and incomplete. Important new knowledge will bemissing, and old and obsolete information will remain

unchanged.

General access to the Internet means that new

knowledge becomes instantly available to all when it

is published. But at the same time the increasing

amount of information is making it impossible to get a

full picture and to assess the quality of the informa-

tion. In addition, the ever-increasing commercialisa-

tion of the medical world means that the development

and the distribution of new knowledge are to a high

degree controlled by forces outside the medical

profession (2,3).In this flow of ever-increasing amounts of informa-

tion, a clinical practice guideline can serve as a filter

and a tool for the clinician to practice up-to-date

evidence-based medicine in the treatment of the

individual patient. In addition, a guideline can be

used as a vehicle for continued professional develop-

ment activities and to support and direct quality

development activities (4).

Guidelines can also be used to purposefully distract

attention, however, to give the public and health

professionals a wrong impression about the relative

importance of diseases and the effectiveness of med-

ical intervention. Examples of guidelines produced by

the pharmaceutical industry to support the busy

clinician and to provide a diagnostic tool for the

‘‘easy detection’’ of diseases are numerous. Or guide-

lines can be introduced by the authorities to control

diagnostic and treatment options and thus restrict

doctors’ freedom of choice (5).

One way to prevent the production of dubious

guidelines is to set up rules for their development and

to make the process transparent. A recent develop-

ment is the Appraisal of Guidelines Research &

Evaluation (AGREE) Collaboration, which has devel-

oped a straightforward check-list for evaluating the

quality of clinical guidelines (6).

�CONTINUOUS MEDICAL EDUCATION AND QUALITY DEVELOPMENT

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Prioritise a few GP relevant topics

According to Canadian criteria, six aspects should be

considered when deciding on a topic: Incidence, cost,

increase in utilisation, regional variances in manage-

ment, evidence that current best guidelines are not

followed and requests from clinicians or organisations

(7).

The initiative for preparation of a guideline often

comes from individuals or a group of clinicians with a

special interest in a particular topic, which will prevent

them from being able to make a reliable judgement of

the importance of their own area of interest. In this

type of committee, GPs may be invited to participate

but will not play a major role.

The national colleges of GPs should identify and

prioritise a limited number of topics based on a

thorough and transparent evaluation (Table I). We

ought not to waste time on guideline committees

driven by special interests, nor should we endorse such

guidelines.

Take the driving seat but invite all stakeholders

If we, as GPs, are to be involved in guideline

preparations, we have to ensure that our persp-

ective is taken into consideration when the topic and

the scope of the guideline are defined. This is

best done if we initiate the process. We have

to acknowledge, however, that the management of

most clinical conditions involves other stake-

holders, and it is important to include them from the

beginning of the process (8). Hospital specialists

possess detailed knowledge about clinical aspects

of the conditions and are key participants, but the

guideline committee should include all stake-

holders with a legitimate interest in the topic. This

will include members of different professional groups,

as well as patients, health administrators and

politicians.

Review of effectiveness: Leave it to others or do it

together

Having defined the clinical questions, the next step is

to identify and review the relevant information.

Criteria must be set up for selecting evidence, sources

of information found, data extracted and conclusions

drawn (6). For each question that the guideline

addresses the different management options should

be presented and a summary given of the findings

from the review process.

Many guideline developers attempt to conduct this

process on their own, but the review process remains

unclear and it is doubtful how rigorous the process

can possibly have been with the resources available in

the guideline committee (9,10).For most guideline topics the task of conducting a

literature review will be too demanding and no group

of even knowledgeable individuals with other commit-

ments can be expected to be able to conduct such an

exercise stringently and comprehensively. At regional

or even national level (at least for smaller nations such

as the Nordic countries) it will be impossible to find

the resources needed in terms of manpower and

finances to carry out full-scale reviews even for a few

conditions. The updating procedure, which should

follow the first version of the guideline, will demand

substantial resources and persistence from those

involved, attributes that cannot always be expected

from volunteers. However, this should not be neces-

sary either. The literature on which reviews are based

is international and the review process itself and the

subsequent updating are also most appropriately

conducted at an international level, e.g. in the

Cochrane collaboration.

Guidelines for osteoporosis, diabetes and dementia

have been developed simultaneously in several Nordic

countries and all guideline committees have gone

through the cumbersome task of conducting a litera-

ture review (11�/14). This may have been unnecessary.

We suggest that our national guideline committees do

Table I. Stages in the development of a clinical guideline.

Stage Level Executing agent Outcome

Selection of topic National National colleges form guidelinecommittee with stakeholders

Clinical questions

Review of effectiveness of treatment International International review bodies Effectiveness of specified optionsReview of other aspects of treatment International/

nationalInternational review body/guideline committee

Implications of the specified aspects

Balancing of different options National Guideline committee Comprehensive managementguideline

Adaptation for local health services Regional Regional guideline committee Regional management guidelineAdaptation for individual practices Patient-contact level Local clinical leadership Practical clinical guideline

Guidelines 3

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not attempt to conduct full-scale literature reviews,

but that instead we should pool our resources and

cooperate to identify existing international literaturereviews or even conduct such reviews jointly.

Effectiveness is but one aspect of disease management

The AGREE collaboration indicates that ‘‘The pa-

tients’ views and preferences should be sought’’, but

apart from clinical effectiveness and patient prefer-

ences many other factors need to be considered before

conclusions can be drawn and a particular clinicalmanagement recommended: Cost, availability of re-

sources, organisational issues and ethics (6).

While the effectiveness of health technologies may

have been published, much less information is avail-

able about these other aspects. It is therefore not

surprising that these aspects are often not covered in

any detail in the published guidelines. However, to the

extent possible, all relevant aspects and possibleoptions should be described in as much detail as

possible at this stage.

The review and description of other relevant aspects

may draw on international experience on aspects such

as economy and may also cut across cultures. How-

ever, organisational issues and patient concerns will

often be context-specific, and therefore need to be

addressed at a national level. A broad composition ofthe guideline committee ensures that these aspects are

considered from the very start of the process.

Recommendations must be balanced and transparent

The clinical effectiveness of different options must be

balanced against each other and against cost and

other important aspects. This part of guideline pre-

paration is highly sensitive to the values and inter-

pretations of those involved in the process, and wesuggest that more attention is paid to this part of the

process.

Literature reviewers should limit their role to

reviewing. They should evaluate the clinical effective-

ness and indicate the level of evidence for each

management option and describe, in as much detail

as possible, other relevant aspects defined by the

guideline committee.Based on the best available information, the guide-

line group must make the recommendations. The

purpose here is to reach a balance between clinical

effectiveness, cost, ethical issues, organisational as-

pects and patient preferences. To be trustworthy, this

process must be explicit and open.

Only a few guidelines present the different options,

and the majority only the bottom-line with therecommendations. To facilitate reading and imple-

mentation a summary section is needed, but it should

be possible to identify the background for the

recommendations in the guideline itself or in its

appendices.

Local adaptation, commitment and resources are

necessary

A comprehensive national guideline will only be used

if it is considered important to those responsible for

the clinical management of the condition, and it will

need to be adapted to fit in with the local structure

and organisation of the health services (15). Each area

of the health services will have different tasks and

responsibilities, and the practical consequences in

terms of new procedures, flow of information and

resources needed for implementation, etc., must be

analysed and agreed upon at the level of implementa-

tion. The national guideline thus needs to be trans-

lated into a local version.

In addition, the clinical unit (hospital department,

primary health care clinic) will also need to develop its

own practical guidelines that detail the implications at

a clinic level and describe what the practical day-to-

day consequences will be for management of the

condition for the clinicians and other staff involved.

Such a practical guideline needs to be developed by

those who will be using it (8). A generic version may

facilitate this process, but to ensure its practicability

the end-users need to develop their own version.

The process of implementation will only succeed if it

receives local commitment and is allocated the neces-

sary resources (16). To ensure that the guideline

becomes a useful tool for the clinician, it is therefore

necessary also at local level to involve all key players,

including patients, health administrators and clini-

cians.

CONCLUSIONS

With our limited resources, the national colleges of

general practice in the Nordic countries should select

only a few important topics and should only get

involved in guideline preparations if they have a

primary care perspective. We need not develop our

own guidelines from scratch, but should take existing

international GP clinical guidelines and literature

reviews as a starting point and conduct the first steps

in the guideline preparation jointly in the Nordic

countries. More effort could then be directed towards

the subsequent stages of the guideline preparations as

well as to the implementation process. Key stake-

holders should be involved at all stages in guideline

development and at all levels of the health services to

ensure commitment and improve the likelihood of

implementation.

4 F. Bro, F.B. Waldorff

Scand J Prim Health Care 2004; 22

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