P-PG/TT(2009)8
Conference
“Guidelines and Recommendations in Drug Treatment –
Bridging the gap between clinical practice and
evidence-based practice”
Nicosia, Cyprus, 11-13 May 2009
Elaboration of MAIN topics from the Conference
Main questions
What is crucial and should be considered (by policy makers) when developing national guidelines for drug treatment?
What should be considered (by policy makers) locally, nationally and on an international (European) level?
A. Background and basic assumptions (why guidelines?)
1. Drug treatment in European countries is still to a large extent based on tradition, belief, hope and interests of others than drug users
2. Principles of knowledge-based medicine are useful for drug treatment as in any other parts of medicine
3. Principles of knowledge-based medicine are basic for developing guidelines
4. Results of registration systems and drug research are necessary conditions for guidelines and knowledge-based work
5. Guideline development is a long-term process, requiring inputs from many kinds of expertise
B. Guidelines
1. There are different types of guidelines, e.g.:
2. Guidelines are a (logical) follow-up of the notion of knowledge-based work/practice
3. The literature shows different definitions of guidelines, but crucial aspects or parts of guidelines are:
i. The less there is scientific evidence, the more guidelines are (necessarily) based on professional experience/expertise
4. Guideline-based choices in drug treatment (in daily practice) should be based on the available scientific evidence and the state-of-the-art in professional experience/expertise (see B-3c) plus patient involvement
5. Scientific evidence may change over the years (e.g. by the results of new high-quality studies)
6. Thus, guidelines should be updated regularly in order to remain based on the latest insights in the available evidence
7. Primary goal of guidelines is maintaining or improving the quality of care
C. Scientific evidence
1. Scientific evidence is retrieved from the international (including - when available - the national) literature
2. This is done with international methodological standards
3. Evidence (sufficient, insufficient, et cetera) can therefore in principle most efficiently be retrieved and determined on international level, but this is rarely done
4. This is partly due to the (still existent!) differences in the grading of evidence (what is sufficient evidence?)
5. These differences in grading evidence can be due to different factors, e.g.:
a. lack of international consensus on a scientifically 'Golden method'
b. differences in grading by researchers, e.g. due to differences in methodological preferences or due to pressures based on morals or interests
6. The evidence base for guidelines
a. Type of study design for different questions
b. Predominantly research on neuroscience (indirectly) and medications used in treatment, but it is a multidisciplinary field
c. Much less research on psychological, social and other issues linked to drug use and treatment
i. We need more research on psychosocial interventions
ii. We need more qualitative research
7. Randomised controlled trials (RCTs)
a. Gold standard in medicine
b. The process of inclusion and exclusion leaves out most of the patients
c. Conclusions based on this type of research, are they relevant in the real world of treating drug dependent patients with somatic and psychiatric co-morbidity?
D. Evidence-based choices of drug treatment in daily practice
1. Knowledge-based drug treatment is based on international (and when available also national) evidence and national professional consensus on experience
2. Guidelines are reasoned action guides for choosing effective treatments
3. This implies changing behaviors/choices of management and professionals
E. The process of making guidelines – focus on these questions are necessary to ensure good processes and good quality guidelines
1. What should be the goal of making guidelines – when should we make guidelines – consider it
a. When practice varies
b. When practice is without effect/harmful
c. When practice is too expensive
2. Who should be responsible for making the guidelines – consider to involve
a. International bodies – can we find guidance?
b. Cooperation with other counties – does a neighbor have anything to contribute?
c. Governmental (national, regional, local) institutions
d. Groups of professionals
e. User representatives?
f. Private actors – pharmaceutical industry, insurance companies?
3. Define who the guidelines shall target
a. Professionals – what groups?
b. Level of care?
c. Users?
F. Implementation of guidelines or evidence-based drug treatment
1. Publishing guidelines presumes that the suggested treatments and care, the recommendations and advice are actually (or to a large extent) implemented
2. Changing choices/behaviors (of management and professionals in drug treatment) in general meets many limiting factors (see the state-of-the-art in the implementation literature)
3. Implementation seems to be easier when guidelines are on a national level (not too generally formulated) reflecting national context characteristics
4. Implementation should be facilitated by persuasion and funding
a. Persuasion and funding are interrelated: one does not work without the other
b. E.g. Persuasion of
i. decision makers of national, regional and local drug policy
ii. managers in the drug treatment field
iii. professionals with different expertise in drug treatment
c. E.g. Funding by
i. national, regional and local governments
ii. medical insurance companies
iii. professional organizations (?)
5. Revision of guidelines are as important as making them
G. Guidelines and drug laws
Existing national drug laws may limit the feasibility of implementing guideline-directed choices for instance because knowledge-based interventions (or specific pharmacological treatments) are illegal (e.g. substitution treatment for opiate users)
H. Guidelines and drug research
1. We lack knowledge about the needs concerning treatments of specific user groups
2. There is a lack of evidence for effectiveness of pharmacological treatment for addiction to other illegal drugs than opiates
3. There is a lack of qualitative research into user groups and context characteristics on local level
4. There is a lack of evidence concerning psychosocial treatment
Guidelines for guidelines
There is no international accepted standard for guideline development.
The following literature could be consulted:
The following paradoxes must be kept in mind
Paradox I
Persons with drug addiction are very diverse and are often suffering from many conditions – medical, psychological and social - requiring multiple interventions simultaneously over a long period of time. RCT and similar effect study designs are generally considered most suitable for studying the effect of simple and relatively brief interventions on clearly defined populations.
Paradox II
Most of the evidence base for substitution treatment concerns the pharmacological part of the treatment. Most treatment for drug abuse also comprises psychosocial interventions.
Paradox III
“Good” science rarely considers context. All human action is linked to certain contextual conditions.
Recommendations
Long term funding of national systems of patient registration (who are the clients to be treated?), monitoring (what kind of treatments are actually used?) and drug research (e.g. experiments on effectiveness of treatment interventions in national contexts) are necessary conditions for guidelines and knowledge-based choices (see A4 and H).
Guidelines are costly and need long-term funding arrangements in order to enable to fulfill their function properly (see A5, B5 and B6).
Funding rules/regulations may increase the rate of acceptance of implementation of guidelines (see E4). For instance, creating (by legal arrangements and funding) systems of monitoring, benchmarking and/or performance indicators the behaviors/choices of decision makers and professionals in drug treatment may be redirected. This should be done after persuasive activities that should alter perceptions of what kind of drug treatment is "good enough" for the clients. Persuasion can also be facilitated by increased international contacts ("hearing other songs") between management and between professionals in drug treatment. These contacts should be actively stimulated.
Application of evidence-based treatment modalities should be legal or legalized (see G).