FEDERAL PUBLIC SERVICE FOR POLITICAL SCIENTIFIC PROGRAM
Substitution treatment in Belgium
Development of a model for evaluation of the different types
of services and of patients
Summary of Final Report, 1e stage
Coordinator: Pr. I. PELC (ULB)
Promotors:
Researchers:
Pr. Dr. J. CASSELMAN (KULeuven)
Isabelle BERGERET (ULB), Philippe CORTEN (ULB), Karolien MEUWISSEN
(KULeuven), Pablo NICAISE (ULB).
November 2003
Faculté de Médecine
Laboratoire de Psychologie Médicale,
d'Alcoologie et d'étude des Toxicomanies
CHU Brugmann – Institut de Psychiatrie
Faculteit Rechtsgeleerdheid
Afdeling Strafrecht, Strafvordering en
Criminologie
Onderzoeksgroep Gerechtelijke
Geestelijke Gezondheidszorg
1
Substitution treatment in Belgium
Development of a model for evaluation of the different types of services and of patients
1. Introduction
1.1.
General frame
The Note de politique fédérale relative à la problématique de la drogue" (Federal political note on drug
problems) has the intention to translate the conclusions of the Consensus Conference on the treatments of
substitution (Gent, 1994) in a restricting legislation. The legal emptiness that persisted until the law of August
22nd 2002 has allowed the development of many practices in this field that need to be evaluated.
1.2.
Mandate
This research has been originated by the Service Public Fédéral de Programmation Politique Scientifique (exSSTC), in the frame of the Supporting Program to the Note de politique fédérale relative à la problématique de
la drogue. It started on August 1st 2002 for a period of 14 month renewable, the first stage ending on September
30th 2003. It is coordinated by Pr. I. Pelc (ULB), and jointly directed by the team of the ' Onderzoeksgroep
Gerechtelijke Geestelijke Gezondheidszorg (Research group on legal mental health care) of the University of
Leuven (KU Leuven) (prom. : Pr. Dr. J. Casselman; researcher: K. Meuwissen) and by the team of the
Laboratoire de Psychologie Médicale, d'Alcoologie et d'étude des Toxicomanies of the Free University of
Brussels (ULB) (prom.: Pr. I. Pelc; researchers: I. Bergeret, Ph. Corten and P. Nicaise).
The present report is the summary of the final report of the first stage of the research.
1.3.
Tasks
Three pilot geographical entities has been chosen for the research; the Province of Hainaut (in the Walloon) the
Province of Limburg (for Flanders) and Brussels.
Task 1: Critical and compared analysis of the legislations in Belgium, France and the Netherlands. Critical
analysis of the international literature; creation of a questionnaire for physicians in view of task 2.
Task 2: General inventory of physicians working in private practices and prescribing treatments of
substitution in the three chosen geographical entities (Provinces of Hainaut, Limburg and Brussels) as well
as the connected ambulatory institutions.
Task 3: Quantitative a qualitative evaluations of the practices of treatments of substitution in the institutions
and by physicians in private practices.
Task 4: Closure
1.4.
Project’s orientation
In Belgium, two major documents set the legal and clinical objectives of the treatments of substitution: the first
one is the text of the Conference on Consensus about treatments of substitution with methadone of October 8th
1994; the other one is the recent law of August 22nd 2002, aiming at the official recognition of the treatments of
substitution and modifying the law of February 24 th 1921 about the circulation of poisonous, sedative, addictive,
disinfecting and antiseptic substances.
2
The present report is based on these external objectives; i.e.;
«We understand under treatment of substitution any treatment consisting in ordering, administrating or
delivering to an addicted patient, within a therapy, a drug under the form of a medicine aiming at improving his
health and his quality of life and if possible obtaining the abstinence of the patient» (Law of august 22nd 2002).
Furthermore, it is expected to observe during the treatment: « a reduction of the consumption of drugs and the
use of needles; an improvement of the therapeutic compliance as well as an improvement of the socioprofessional skills and a reduction of delinquent activities. ».
1.5.
Context of the research
This study has to take into account the specific context in which the treatments of substitution happen in
Belgium, more precisely: 1) the complex and vague nature of the organisation of the different types of assistance
by treatment of substitution in Belgium (for example; the lack of inventory of all the actors applying these
treatments and the diversity of the practices – objectives, application modalities, criteria of admission and the
many possible interpretation of the recommendations of the Consensus Conference of 1994. and 2) the lack of a
general and efficient method of evaluation of these services in Belgium.
2.
Objectives and goals
2.1.
Aim
2.1.1
Definition and general objectives of the treatments of substitution
The research lies within the general frame of the study of drug-addiction, particularly the treatments of
substitution. The law of August 22nd 2002 gives a definition of the treatments of substitution as well as the goals
they should pursue.
2.1.2. Intermediary objectives of the research
The intermediary objective in this first stage of the research is to build on the basis of existing tools and the
experience of professionals on the field, an evaluation instrument adapted to the practices in Belgium and to the
specific conditions of the each of the channels of assistance.
This research has as particular objective, the study of the many practical access modalities to ambulatory
treatment of substitution, being:
1) the « Maisons d'Accueil Socio-Sanitaire pour usagers de drogues » (MASS) — (Socio-sanitary homes for
addicted patients). A detailed evaluation has already been completed by the SSTC (Pelc & al. 2001);
2) the ambulatory institutions specialised in following the addicted patients (called “session centres”)
3) physicians organised in assistance networks;
4) physicians in private practices.
2.2.
Goals:
In order to reach these objectives, it has been decided to create one of more questionnaires evaluating the
treatments of substitution according to the criteria’s mentioned in the general objectives. This, or these
questionnaires, should also be applicable to the various Belgian contexts of treatments of substitution as
mentioned in the intermediary objectives. This great diversity of practices constitutes the major difficulty in the
construction of such tools.
2.3.
Targets:
In order to achieve this goal, three intermediary stages have been distinguished:
2.3.1. Feasibility analysis of the use of the pre-existing validated questionnaires:
(Addiction Severity Index (ASI) (McLellan & al 1992), and Questionnaire de Qualité de Vie Subjective
(Quavisub) (Corten 1998))
2.3.2. Gathering of important qualitative data for the participants (Institutional Supervision and
Focus groups)
2.3.3. Searching for other existing tools
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3.
Juridical aspects and international literature
Critical analysis of the juridical situation about the treatments of substitution in Belgium, France and the
Netherlands. (KULeuven)
Definition
In this study, the juridical and legal aspects of the treatments of substitution are to be considered from a broad
point of view. We prefer to speak about rules, because it includes not only formal laws but also more generally
(professional) guidelines, precedents, doctrine, government’s documents…etc that occur not only on the
international of national level but also on the local level.
International rules
Prior to the study of the juridical aspects of the treatments of substitution in some European countries, it is
important to first precisely define the international legal frame all European countries have to take into account
when establishing rules and building a network of assistance for drug addicted.
The most significant legal basis for treatments of substitution on the international level is to be found in the UNtreaty of 1961 about drugs (‘A treaty about narcotic medications’ ), of 1971 (‘Treaty concerning psychotropic
drugs’) and of 1988 (‘Treaty related to smuggling of narcotic and psychotropic drugs’).
On the basis of the regulations of these treaties, a large majority of the people on the field and of the decision
makers mean to consider the use of treatments of substitution (with methadone and possibly other replacement
medications) as a legitimate form of help to addicted patients aiming at a reduction of drug abuses. This is and
remains a question of interpretation, considering the fact that the treaties do not explicitly name this kind of help
as such, but follow a classification system of lists of different substances and the measures of control proper to
each list. The use, possession, production… etc of the listed substances are, according to the treaties, “in
principle prohibited, except for medical or scientific purposes”. This way, the discussion about controlled
medical prescribing of heroine keeps arising.
Europe
In Europe, the practice of treatment of substitution developed in the 70’s and 80’s while the legal basis for it only
occurred in the 90’s.
Rules in Belgium, France and the Netherlands
The major observation that can be made is that even though they are neighbours there is a great diversity
between the three countries concerning the rules on treatments of substitution.
The Netherlands started quite soon with a real “progressive” policy by choosing (also on a legal basis) a harm
reduction-approach, preferring methadone treatments for patients addicted to opiates. There is presently a large
consensus on the objectives of the treatment; the major one being the reduction of health problems and the
improvement of the social situation of the consumer of drugs. In the early 80’s, more than half the actors
involved had as major goal the abstinence of the patient. The organisation and modalities of the treatment vary
a lot due to the fact that local authorities take specific regulations about treatments of substitution.
In Belgium, the treatments of substitution appeared on a small scale in the late 70’s, though legally prohibited
(some physicians suffered penal condemnations for prescribing methadone). Rule makers and people on the field
turned progressively to a more positive approach of this kind of treatment, but it’s only in 2002 that a formal
law finally acknowledges this trend. Doing so Belgium is the last European country to rule about treatments of
substitution. However, this has led to a somewhat “hypocrite” situation; on the one hand administrating
treatments of substitution remained punishable all the time; on the other hand “guidelines” already existed since
1994, having no force of law, but based on a very large consensus of all actors involved. Furthermore, these
guidelines were, from the beginning on, very liberal. The application decree, which will set the implementation
rules of the general regulations of the law, is almost ready (end 2003).
France, on the contrary, has always followed a strong approach in the field of drug addiction. Today this
severity is going on if we consider the laws about prescribing and administrating methadone. This may only
happen in a few specialised centres (under strict conditions and often with a view to abstinence) that absolutely
do not meet the much larger needs of the patients. Physicians still preferring treatments of substitution see
themselves obliged to go around the rules and prescribe a substance named Subutex which use for medical
purposes has not been ruled yet.
The last two or three years, some changes were noticeable (more centres, a liberal approach). But Subutex
remains the most prescribed substance.
4
Recommendations
The following recommendations are based on a large consensus of the people on the field and the decision
makers in different European countries (among which Belgium, France and the Netherlands). However, we have
to mention that there will still be people to disapprove these recommendations. Apparently, until today, the
subject of treatments of substitution remains heavily controversial.
- Treatments of substitution should be applied on a broader scale, and also more accessible centres and harmreductive initiatives in general.
- Treatments of substitution should be based on a solid legal basis, with clear rules, leaving enough space for
the people on the field to differentiate, considering the large differences existing among the drug users,
specific local situations ... etc
- The rules on treatments of substitution should mainly be flexible, in order to adapt the treatment to specific
situations of patients/clients. (For example: flexibility of the conditions of access, more attention to the
follow-up (unlimited duration) aiming at harm-reduction instead of abstinence, enlargement of the lists of
authorised substitution substances – including medical prescription of heroine for a selected group of utmost
marginalized and problematic users).
- As many actors as possible should be involved in treatments of substitution; next to specialised centres,
physicians, pharmacist, general health centres, (psychiatric) hospitals and jails.
- Opportunities of complementary psychosocial support should be extended for users for whom dependence
goes together with important psychosocial problems.
- There is need for more scientific research, namely evaluations via accurate registration data completed with
qualitative research.
- There is need for a better education and continuous professional training for all actors involved especially
physicians.
3.2.
International Scientific Literature Overview
3.2.1.
Treatments of substitution and drug-addiction
3.2.1.1.
History of treatments of substitution
Speaking of legal substitution products in replacement of prohibited products, (which is de facto the case with
methadone as substitution for heroin) and especially considering the legal frame as presented above, it is
important to keep in mind that law did not always prohibit this substances. On the contrary, on the scale of
history, the prohibition of opiates is relatively recent. But, if we replace this assertion in its real historical
context, its impact changes. Heroin having been synthesised in 1898 (cocaine in 1860) it couldn’t have been
prohibited sooner. When discovered, these substances knew a sort of fad, especially on a recreational level (like
originally the mariani wine or Coca-Cola). Laudanum (opium liquor) was at the time frequently prescribed as
stress reliever (already!), chronic and acute disturbance causing a sort of iatrogenic dependence.
At the end of the 19th century, two thirds of the individuals addicted to opiates were middle-class (or high-class)
aged white women, and one third were war-crippled or mutilated persons. (At the end of the 19th century, the
number of drug addicted is estimated to 300.000 persons). The attitude towards these women was more
compassionate. But very soon, the disastrous effects of these habits appeared, and rules were established
concerning the commerce and use of it. These rules were more like “informal control mechanisms” (Jay M,
2002). Therefore, the addiction in these two groups strongly decreased.
The composition of the addicted population in the USA changed completely in the beginning of the 20th century
with the immigration flow, coming from Northern European in the first place, then from China and the
Caribbean. It essentially developed in the ghettos and poor neighbourhoods where criminality already existed
and this led to a stigmatisation of drug-addiction.
5
This shift within the addicted population is not sufficient to account for the prohibition of narcotics and drugs.
Several factors can be named (De Kort M, 1995):
1) Economic and strategic interests.
2) Moral reasons: (namely the Temperance Movement in the USA).
3) The interests of the medical profession.
4) The local economic interests of the cotton lobby and the hemp lobby in the USA.
This medico legal context led the Narcotics Division to review its position. In the late 60’s, the first cause of
mortality among young adults (between 15 and 35 years old) in New York was due to heroin.
The cases of hepatitis were drastically increasing. The number of drug-addicted arrested for misdemeanour
related to drugs overcrowded the jails though no efficient treatment could be given in prison. This is when Dr
Vincent Dole became president of the” Narcotic Committee of the Health Research Council of New-York City”
and was asked to study the feasibility of a replacement treatment for opiates.
It is also interesting to refer to the “Experience of Liverpool”, where, not only the notion of « harm reduction »
originated but also the first “political” recognition of the treatments of substitution.
This is Great Britain in the 80’s; in Liverpool the industrial conversion is ravaging, and Aids has just appeared.
Taking advantage of a legal emptiness in the British legislation, several physicians, - the most famous among
them is Dr. J. Marks – experienced prescribing several narcotics (mostly heroin and cocaine) to marginalized
drug-addicted patients reluctant to any other kind of treatment.
If, in terms of abstinence, this approach seemed of no interest, it brought up, however, surprising sanitary results.
The drug-addicted had no longer to look for money to buy their products, officially sold by the pharmacist at
cost price. In a sense, they were offered new chances of a normalised social life, and maybe job opportunities.
The availability of the products meaning no longer a financial pressure, criminality decreases significantly at the
same time. Also, drug use happens in hygienic places, and the substance delivered is of greater purity (Henmann
A, 1996). All sanitary complications are thus eliminated, and the impact on the Aids proliferation is undeniable.
Therefore, even if methadone is the most known and used substance, it is important to keep in mind that other
substances do exist, and this is why we speak about « treatments of substitution ».
More precisely, the prescription of heroine makes fully part of the treatments of substitution. In Switzerland, the
controlled medical distribution of heroine exists since 1994, since 1997 in the Netherlands, and more recently in
Germany and Spain. Great Britain prescribes heroin for a decennia already, but on a very limited scale and on a very
selective basis (Meuwissen K et al, 2003).
3.2.1.2. Literature Review
The notion of treatment of substitution can be understood in a broad or restricted way. In its largest sense, it
means replacing the illegal use –thus clandestine– of opiates, by another product easier to control. We can
describe three philosophies of approach:
 The philosophy of substitution stricto sensu: a prescribed opiate replaces an illegal opiate -methadone,
buprenorphine,… -;
 The antagonist philosophy.
 The philosophy of symptoms-reduction.
Our study focuses on the philosophy of substitution stricto sensu.
Concerning treatments of substitution of heroin in it’s restricted sense, two products are mostly used and
described in the literature, namely: methadone and buprenorphine.
1) Methadone
 The guidelines of the Department of Health
For many years, the « State Methadone Treatment Guidelines » jointly published by the US Department of
Health and Human Services and the Foundation Phoenix (Parrino MW, 1992) was the reference for methadone
treatments good practices.
It sets guidelines on the following aspects:
a. Clinical aspects of methadone treatment
b. Policies and admission procedures
c. Principles of determination of methadone doses
d. Urine analysis as clinical tool
e. Responsible practices in terms of take-away methadone
f. Multiple drug-addictions treatments
g. Maintaining methadone during pregnancy
h. Infectious diseases and Aids
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i. Treatment duration and patient retention
j. Integration of methadone programs to the community
 Conference on Consensus and it’s follow-up by CSH
The Conference on Consensus on methadone took place in Gent in October 1994 (Ministry of Public HealthBelgium, 1994). Several years later, in 2000, the Conseil Supérieur d’Hygiène published a report of follow-up
of the Conference.
This Conference as well as the follow-up report agree on what should be expected during the treatment: « a
reduction of the consumption of drugs and the use of needle; an improvement of the therapeutic ‘compliance’ as
well as an improvement of the socio-professional skills and a reduction of delinquent activities ». The same
way, we expect to notice a reduction of the Aids transmission risks as well as a decrease of overdoses, hepatitis,
complications and mortality.
 Other articles
In France, from 1973 to 1995, treatments of substitution were long limited to methadone delivery by two
experimental centres. About the dosages, we could notice higher doses than the average doses of 110 mg
methadone daily.
In Belgium, any physician can deliver the treatment by methadone.
Since the Conference on Consensus in Gent, general practitioners of the network “Alternatives for DrugAddictions (ALTO) have treated thousands of drug-users. The practitioners of the project ALTO evaluated the
practice of substitution by methadone. It proved to be efficient for the stabilization and the reinsertion of the
patients and the therapeutic compliance is satisfactory. On the other side, concerning the psychological balance
and use of products, the patients seemed less stabilized.
2) Buprenorphine
In France since 1996, the sanitary systems has made Subutex available (Buprenorphine high dosage). The
galenic form of buprenorphine and its pharmacological properties as long-term partially agonist, offer a safe
frame. The prescription and delivery modalities vary from methadone. Any exercising physician at all is
authorised to prescribe buprenorphine high dosage. It is therefore, more prescribed in France (Observatoire
Français des Drogues et des Toxicomanies ,2001)
3) Comparison between methadone and buprenorphine and linked mental representation
Its seems that the environment of consumption as well as the mental representation of the substances influence
more the choice of the consumer and the physician than it’s pharmacological properties. In France, methadone
has a connotation of last chance medication, therefore given in extreme situations. This image of methadone has
not been observed in other countries were it has been used for a long time.
4) Benefits of treatments of substitution
Treatments of substitution offer the opportunity of certain stability, preventing the succession of intoxication
phases with withdrawal phases, generating behaviour problems implying social and relational difficulties. It
allows long-term projects and the possibility of regaining balanced social and relational contacts, where under
family relations.
Throughout the literature review (Avants S et al, 1999, Auriacombe M et al, 1994, Trémeau F et al, 2002), we
find documents assessing that the beneficial effects of the treatments of substitution are to reduce the illegal use
of opiates, originate a reduction of criminality, to reduce mortality due to HIV infection and improve social
reinsertion.
Furthermore, the duration of the treatment seems a very important factor for predicting the chances of success
and maintaining the achieved improvements after leaving the centre.
The professional domain seems to know the slowest improvements (improvement in 24 months)
(Duburcq A et al. 1999). Numerous studies have used the ASI (McLellan AT et al, 1982, Martin C et
al, 1996, Strain EC et al, 1996) to put into light the possible changes in the different domains
investigated by the instrument.
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3.2.2. Quality of life
The analysis of the international literature (Corten Ph, 1998) shows that this label is used in three general
dimensions (Mercier C, 1994) :
 The environmental Quality of Life

The Quality
of Life related to health

The Quality
of Life related to all life domains and considered as a whole.
The present study lies in the line of the third one, because Quality of life of drug-addicted is not limited to the
health dimension. The subjective quality of life or « quality of life as a whole ” relies essentially on the
subjective experience, strengthening this importance of taking into account all life domains. Corten et al. (2002)
have demonstrated that this model is heuristic not only for healthy subjects but also for mentally ill patients or
patients presenting addictions, and that life domains relies on four important dimensions: material life, relational
life, social life and self-image.
3.2.3 Evaluation tools
3.2.3.1.
Addiction Severity Index (ASI)
Description of the tool
The Addiction Severity Index (ASI) is a semi-structured instrument worked out in 1980 by an American team
directed by McLellan (1995). This clinical instrument measures the severity of drug- addictions and evaluates
the patient’s need for treatment from the seven following points of view: medical state; employment and income;
alcohol use; drug use; legal situation; family relations and social contacts; psychiatric or psychological state.
The ASI gathers not only subjective information (patient’s concerns in the domain of investigation) but also
objective information– number, scope and duration of the symptoms in all life domains during the last 30 days -.
This data will lead to the calculation of two scores: the severity score and the composite score. The severity
score is calculated on the basis of items about the patient’s preoccupations, the evaluations of its perceived need
for treatments, and the so-called “critical items” in the investigated dimension. The clinical interest of this
severity score relies on the fact that it allows the evaluations of the patient’s subjective need for treatment and
also the adaptation of the treatment at any time.
The composite score, on the other hand, is essentially interesting for research. It is calculated on the basis of
« critical » items related to « objective data ».
Validity, reliability and relevance of the ASI
Although, according to McLellan (creator of the instrument), the ASI has been used by more than a thousand
treatment centres, and it has been translated in more than 9 different languages, apart from the author’s studies
(McLellan AT et al, 1980, 1985, 1992, Zanis DA et al, 1994) there are no more than ten studies about the
validity of the instrument (Kosten TR et al, 1983, Hendricks VM et al, 1989, Hodgins DC et al, 1992, McCuster
J et al, 1994, Alterman AI et al, 1994, Drake RE et al, 1995, Joyner LM et al, 1996, Rosen CS et al, 2000,
Leonhard C et al, 2000, Bovasso GB et al, 2001, Butler SF et al, 2001).
Its properties are as follows:
1. The estimation of test-retest reliability after three days lies between the following range: r = 0.84 to r = 0.95;
2. The inter-raters fidelity to severity scores lies between r = 0.74 and r = 0.99 ;
3. The instrument is sensitive enough to measure the changes during the treatment.
4. The internal consistency of the composite scores goes from 0.56 for employment and income to 0.85 for
alcohol use; but the results show that the alpha coefficient of Cronbach (1951) per domain is very variable from
one study to another:
5. The ASI allows the treatments to adapt to the needs of the patient.
The advantages of the ASI are its translation in many languages, fitting to the cultural differences and its
validation. Numerous European countries (France, Germany, Italy, Greece, the Netherlands and Spain) have
translated the ASI and brought the adaptations according to their cultural specificities. A standardized version
exists under the name of EuropASI (Kokkevi, A., et al. 1995, Lafitte, C. et al., 1998). The psychometric data of
this version is similar to the one calculated for the ASI. However, in the French part of this report we used the
translated American version and not the French translation of the EuropAsi.
8
3.2.3.2.
Quavisub
Description of the tool
In this research the Quality of life instrument we used is Quavisub. Quality of life is defined as a cognitive
judgement of the evaluated person in different life domains, his subjective well being related to his aspirations
and expectations.
Quavisub is an instrument of self-evaluation of the subjective quality of life. It is a tool composed of several
validated sub-scales:
1.
The Satisfaction with Life Domains Scale (SLDS) of Baker and Intigliata (1982) modified by Corten
and Mercier (1997 et Caron J et al, 1997) measuring the subjective satisfaction in 20 life domains;
2.
The Importance of Life Domains Scale (ILDS) of Corten and Mercier (1997) measuring the importance
attributed to 20 life domains of the SLDS
3.
The Life Ladder of Cantril (1965) measuring the aspirations and expectations of the interviewed;
4.
The scale of interdependence of Corten and Mercier (1997) measuring the richness and diversity of the
social support;
5.
The Social anxiety scale of Richardson & Tasto (1976) measuring the way a subject reacts to
disregarding attitudes of others;
6. The Performance Scale of Smith and Linn measuring a person’s attraction to performances;
7. The Questionnaire on drinking habits of Pelc.1
For the needs of the research, we asked the authors to add to the basic set of scales, a scale on substances and the
sensations they give.
Validity, reliability and relevance of the Quavisub
The psychometric properties have been studied for each scale (Corten and al., 1997):
1. The estimation of test-retest reliability after four days lies between the following range r= 0.89 to r=1.0
according t the scales.
2. The instrument is sensitive enough to detect changes during the treatment (tested after 4 months).
3. The alpha coefficient of Cronbach is excellent for each sub-scale.
3.2.3.3. TUF
The "Treatment Unit Form" (TUF) is an instrument developed by a team of researchers around the Greek Focal
Point of the REITOX network of the European Drug Observatory (June 1997) 2. It’s objective is to allow the
development, on the scale of the European Union, of a standardized typology of the different type of assistance
and services to the drug addicted. It has been chosen, in the frame of this study for its descriptive value and not
for its statistical value.
1
Pelc I. Echelle d'évaluation des Habitudes de Boisson, in Cottraux J., Bouvard M., et Legeron P.; Méthodes et échelles
d'évaluation du comportement, Ed. Applications Psychotechniques, Issy-les-Moulineaux, 1985, pp. 232-235.
2 http://eibdata.emcdda.org/Treatment/Process/ttuf.shtml, 20/08/03
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4.
4.1.
Procedure
Selection of Institutions (Methodology)
4.1.1. Definition of the term « institution »:
As specified in the intermediary objectives, this research had as particular objective to study the different
practical modalities of access to ambulatory treatments of substitution. We do not consider the practitioners in
private practices as institutions. However, they will be invited to the discussions groups for the qualitative part of
the study.
4.1.2. Province of Hainaut
In the province of Hainaut, the present research has focused on the region of Charleroi, due to the relatively high
prevalence of drug-addiction problems, and the possibility to refer to existing information already collected for
the evaluation of the MASS (Pelc I et al, 2001). Among the institutions screened, the authors identified:
1) The MASS of Charleroi (Diapason)
2) Specialised ambulatory institutions: les Collectifs de Santé de Charleroi-Nord et de Gilly-Haies
3) The « Alto » network
Although considered as a network for the Hainaut, the cooperation with the Alto network of Charleroi was of no
use, the physicians exercising also in specialised institutions of the region.
4.1.3. Brussels (French Speaking part)
In Brussels (French speaking doctors) the following institutions were approached:
1) MASS of Brussels
2) Specialised ambulatory institutions: LAMA project
The participation of the Lama Project seemed essential. However, this institution could be part of our sampling.
3) « R.A.T. » Network (Assistance Network for drug-addicted)
Finally, it has not been possible to integrate the RAT to the study; the major obstacle being that RAT uses
another instrument, the Evolutox, still internally evaluated.
4.1.4. Province of Limburg
1) MSOC-Limburg: The MASS is in fact the only ambulatory centre in Limburg working with treatments of
substitution.
2) Specialised ambulatory centres: in Limburg, there is no other ambulatory centre working with treatments of
substitution.
3) Network practitioners: there are no network practitioners in Limburg, unless we consider the mandatory
practitioners as such. (They are part of the network MASS)
4) Liberal Practitioners: see infra 4.3.
4.1.5. Brussels (Dutch-speaking part)
1) MSOC: There is no specific Dutch speaking MASS in Brussels. Officially, the MASS of Brussels is
bilingual.
2) Specialised ambulatory centres: we identified 2 centres -: Transit and the day-centre De Sleutel.
3) Private physicians: refer infra 4.3.
4.2. Selection Method of the cases in this study.
4.2.1. Province of Hainaut and Brussels (French-speaking)
For each institution, random stratified samplings have been constituted. Only patients following a treatment of
substitution at the time were eligible. Each institution reproduced the proportions of the activity reports in terms
of age and sex, over a sample of 30 patients. On the other hand, a control group has been established for the
Quavisub. This control group is based on the available data of the authors of the questionnaire. Each patient is
associated to a control-person in good health of a same gender, same age category, and same educational level.
10
4.2.2. Province of Limburg
After having provided the MASS of Genk (central antenna) with concrete information about the research the
coordinator accepted to fill in a « TUF » and collaborate for the representative sampling of 30 patients among the
methadone clients. When we collected patients questionnaires (Quavisub and EuropAsi) somme practical
problems appeared: essentially because the searcher must herself applied the questionnaires (What take a lot of
time) and also because nobody came to the appointments.
4.2.3. Brussels (Dutch-speaking)
Transit faced the same practical problems (spent of time and uncompliance to appointment) at the time, having
the questionnaires filled-in (EuropASI) or helping the patients to fill them in. For the day-centre De Sleutel, we
will contact, in the second part of the project, Me Veerle Raes, responsible for processing the data about patients
at De Sleutel.
4.3.
Inventory of the professionals
The objective of the inventory was to, first, identify the physicians prescribing treatments of substitution, the
extent of the practice, the number of patients, and then, to constitute, in each entity a sample of physicians for
the other tasks of the research.
4.3.1. Province of Hainaut and Brussels (French-speaking)
The Order of Physicians in Brussels and the Province of Hainaut and the Order of French Speaking Physicians of
Brabant provided us with the full list of physicians. The questionnaire, built up as task 1 has been sent to the
following specialties: general medicine, gynaecology-obstetric, internal medicine, neurology, neuropsychiatry,
psychiatry, military medicine and applicants specialised in this field. A data- base had been worked-out to process the
answers the answers of the questionnaire.
It represents 2641 questionnaires posted for the Province of Hainaut, and 4233 questionnaires posted for the
region of Brussels (French-speaking physicians).
4.3.2. Province of Limburg and Brussels (speaking-speaking physicians)
The Medical Director of the MASS of Limburg provided us with the full list of physicians in Limburg. The most
relevant specialties were taken into account: general practitioners, internists, gynaecologists, neurologists,
psychiatrists, neuro-psychiatrists, military doctors and post-graduate students in this field. In total 1235
questionnaires were posted in Limburg and 278 at Brussels.
4.4. Focus groups
Discussion groups took place in each geographical pilot entity. These groups were composed of physicians
applying treatments of substitution in private practices.
The objective of the groups was to determine the modalities of the treatments and it’s specificities compared to
the institutional practices the problems of psychosocial assistance and the place of the practitioner in the whole
system.
4.5.
Institutional Intervision
The institutional intervision has been used as qualitative method to guide the institutions in the frame of the
research. Although, like focus groups, organised in discussion groups with participants, its objectives is almost at
the opposite. In fact, if the primary objective of the focus groups is to bring out as many different opinions as
possible, the objective of the institutional intervision is to reach a consensus among individuals participating in a
same group.
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5. Results
5.1.
Quantitative Evaluation (ASI, Quavisub)
5.1.1 Addiction Severity Index
5.1.1.1 Collecting data: proposed and filled-in questionnaire
According to the experimental protocol 30 filled and validated questionnaires per institution were to be collected
(in total 120 questionnaires). The ASI having been used in more than a thousand studies in the world, this
objective did not seem out of reach. However, in this particular case, the questionnaire had to be tested on its
feasibility on a daily basis, as a routine, filled-in by doctors and not by researchers specially appointed to do so.
It seems that on the French speaking part, once started with, the questionnaires have been returned to the
research team fully completed and validated, which was not the case in the Dutch-speaking part. Finally not a
single institution has reached the objectives of 30 completed tests. The clinicians seem to complain about the
long time necessary to fill in the questionnaire in proportion to the limited time of a consultation; also the
information gathered by the ASI brings no added value to their practice.
5.1.1.3. Face validity
The ASI seems to meet perfectly the evaluation criteria of the law and the conference on consensus, except for
the one on Quality of Life.
The items proposed in ASI mainly focus on elements of deficiency. Most of the questions of the ASI concern
objective elements requiring each time some thinking. The average duration of the ASI test in this study is 53
minutes.
According to the interviewed persons, some questions seemed too intrusive, particularly the one on revenues and
expenses, their sequence was not always favourable, the systematic explorations of the legal past, even with no
link to the actual drug-addiction problem made them feel uncomfortable.
Also, processing the data requires regular checks in the manuals and makes preliminary training vital.
Furthermore, on the metric plan, the ASI uses different gaps: 5 levels for the scores of preoccupation and
importance, 10 for the severity, 30 for the monthly frequency, from 0 to 1 for composite scores… This
variability of gap increases the complexity of the work.
5.1.1.4. Intern Validity
The ASI shows a very strong internal consistency in the medical, legal and psychiatric dimension. The social
relationships dimension is the less represented. Finally, in the dimension of drug use, the severity index fits
correctly the opinion of the patient, but remains independent of the composite scores supposed to reflect the
objective situation.
5.1.1.5. Construct Validity
The analysis of the international literature has shown that composite scores reached an acceptable alpha
coefficient of Cronbach in most of the scores except for the drug dimension. Despite the size of the sample
(N=15), the  has been recalculated. Only the "medical” scores and "work" scores clearly exceed the thresholds,
but the "drug" score is not sufficient.
5.1.2.
Quavisub
5.1.2.1
Data collection
In the experimental protocol 30 completed and validated questionnaires per institution were to be collected (in
total 120 questionnaires). The objective was to evaluate the feasibility of the use of this instrument on a daily
basis, a routine work to be done by the participants themselves and not the researchers. On the French speaking
part, one institution (MASS of Charleroi) has reached the objective. However, in private practices, the proposed
version of the questionnaire raises practical difficulties. The questionnaire being too long to be filled-in in the
waiting room, a number of patients took it home but never returned the questionnaire back on the next
appointment.
5.1.2.3. Face validity
The Quavisub is a tool aiming at evaluating the Quality of Life. By construct, it is not meant to deal with specific
problem. In reference to the objectives of the law and of the Consensus Conference, it measures the Quality of
Life in different life domains (material life, relational life, social and professional life, self-image, health…) but
does not include references on delinquency or the use of needles (although a set of items concern substances and
addictive behaviour).
12
Globally, Quavisub gives priority to subjective and qualitative answers. It is also more oriented towards the
clinical practice (average of long version), because it meets the preoccupations of the physicians and stresses the
strategies of Quality of Life of the interviewed. Compared to the ASI, this questionnaire insists on what goes
well (and not only on deficiencies, although registered) and on what could be improved.
Concerning drug-addictions, the originality of this questionnaire is to propose a scale of satisfaction depending
on the products used or the addictive habits of the person (alcohol, tobacco, drugs, medication, pathologic
gambles…)
5.1.2.4. Intern validity
As described in the methodological chapter, paired samples have been worked-out, with persons in good health
of the same age, gender and educational level. The satisfaction scales as well as the scale of importance or of
objective domains show a significant difference between the two groups. Concerning the strategies, only
independence and daily self-care strategies do show clear differences between the two groups. But on the other
hand, there is no significant difference in the identification to performance strategies and the negative impact of
the social pressure.
Furthermore, a logistic analysis of the two groups (Wald Method) shows that 93.7% of the cases are correctly
classified if we select the following variable composite:
1. Importance of self-image and health
2. Objective material life
3. Objective social life
4. Self esteem and life scale
5. Alcohol use and it’s modifying effect on consciousness.
Moreover, the analysis of the hierarchy of clusters shows that we can easily distinguish, within the sample, 3
different groups of drug-addicted patients (6, 12 and 18 cases).
5.1.2.5. Construct validity
All the Quavisub scales, except the one on performance, score above the minimum thresholds.
5.1.3.
Inventory of results of the survey by questionnaire
As we already stressed, this inventory is meant as an opinion survey, particularly for physicians, applying or
having practiced treatments of substitution, and not an epidemiological survey on a representative sample of
physicians (the relevance of the opinion of the practitioners never having been consulted by a drug addicted is
outside the scope of this study).
5.1.3.1. Province of Hainaut and Brussels
The questionnaire has been sent to 2.641 physicians in the province of Hainaut, and to 4.233 physicians in the
region of Brussels (Fr.). 253 questionnaires were returned by mail from the province of Hainaut (9.6% of
answers) and 430 from Brussels (10.2%of answers).
Among the data collected (N=683), 45.38% of the physicians had experienced prescribing treatments of
substitution to drug addicted. 54.61% do not have nor a private practice nor drug addicted patients. 19.9% have
a private practice and patients presenting drug addiction problems and 5.1% have no private practice but do have
drug-addicted patients.



1. Physicians exercising in private practices and applying treatments of substitution.
Modalities of practices (170 physicians): 127 physicians confirm following a protocol of substitution stricto
sensu (according to the Conference on Consensus), 103 treatments of rapid withdrawal and 114 maintenance
treatments. (Not mutually excluding classes)
Frequency of the patients/physicians meetings (170 physicians): 56 physicians see their patients 1x every
two weeks, 51 1x per month, 39 more frequently and 19 irregularly.
Number of patients by physicians exercising in private practices (170 physicians): the physicians in private
practices have generally few patients treated, 54 have 1 or 2 patients, 66 from 3 to 10.
13
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




2. Physicians applying or having practiced treatments of substitution.
This physicians are more in favour of heroin prescription for drug addicted
This physicians are more in favour of a standardized and centralised registration of the patients in treatment
This physicians are more in favour of compulsory support and training for physicians
This physicians are more in favour of reimbursement of subutex or naltrexone by the insurances
These physicians are more in favour of an obligation of psychosocial assistance for patient following a
treatment of substitution.
3. Physicians not practicing or no longer practicing treatments of substitution.
Transferring the requests towards other institutions:
36.5% of the physicians do not or no longer practice treatments of substitution and declare referring to an
institution while 24,8% refer to a colleague psychiatrist. A significant difference is observed between the
respective way or transferring this request. The physicians in Brussels refer more to an institution, while
physicians in the province of Hainaut refer to a general practitioner.
5.2.1.2. Province of Limburg and Brussels (Dutch speaking doctors)
In the beginning of the research, we developed a simple questionnaire and sent by post to all physicians in the
pilot region (namely general practitioners, internists, gynaecologists and neuro-physicians) – for the KU Leuven;
province of Limburg and Brussels; Dutch speaking doctors -. The objective of this questionnaire was to establish
a list as complete as possible, of all the physicians applying treatments of substitution for drug-addicted. The
doctors involved had to answer several questions about the number of patients treated, the modalities of
treatment and the substances prescribed…etc. Any respondent could answer these questions. We give hereunder
an overview of our principal conclusions.
Answers
For the province of Limburg 406 physicians out of 1235 answered: an answer rate of 33%. From the 406
answers 45 physicians (11%) apply treatments of substitution. This rather low percentage is due to the specific
situation of the Province of Limburg, where a system of mandatory physicians (GHA) has been developed;
some physicians are appointed by a group of physicians to specially treat all patients dealing with illegal drugaddiction problems (among which patients receiving treatments of substitution) /
In Brussels, the rate of answers is lower; 21% (59 of the 278 physicians contacted), but the percentage of
physicians applying treatments of substitution is higher; 20,3%.
Reasons for not applying treatments of substitution
In Limburg, the responding doctors who do not apply treatments of substitution do transfer, in most cases,
(almost 40%) the patients asking for substitution treatment to a colleague (mandatory) physician, or a specialised
institution, or in some isolated cases to a colleague psychiatrist. Also, more than a fourth of the responding
doctors receive no such request. It is striking to notice that almost 20% of the responding physicians do not
consider themselves competent enough to treat a patient with (illegal) drug-addiction problems. This can lead us
to conclude that there is a lack of attention given to drug-addiction problems during medical schools and later
trainings for physicians. Last but not least, 10% of the responding doctors “avoid contacts with drug users”, what
is not unimportant.
The answers of the physicians in Brussels do lie in the line of the answers of the province of Limburg, except
that less physicians do actually transfer their patients, and also that more physician uses the “other” type of
answer.
In the first place, even if there is a transfer of patients (far less than 30%), they mostly choose to transfer the
patient to a specialised institution, then, to a limited extent, to a colleague practitioner or a psychiatrist. Also,
they argue that they almost never get this kind of request (+/- 25%). There is reason to doubt that this doesn’t
mean that this type of request does not exist. While discussing with physicians in Brussels, we believe there is a
more realistic explanation. The Order of physicians of Brussels takes particularly drastic measures against
physicians prescribing substitution medication; therefore users do turn to French-speaking practitioners.
An equally large group of responding physicians in Limburg do not find themselves competent enough to treat
(illegal) drug-addicted. Next to last, “avoiding contacts with drug-users” represents more than 12% of the
answers. As mentioned already, the category “other” has been a frequently used answer among physicians of
Brussels. Conversations with doctors, lead us again to conclude that the Order of physicians adopts rather severe
positions against treatments of substitution. Here again, the reason given, that we had foreseen in our closed
questions range, namely; “one feels uncomfortable when drug-addicted knock on their door”.
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Number of patients, substances and contact-frequency
Considering only the answers of the physicians really applying substitution treatments, we can only draw general
trends, based on the limited amount of answers. (Limburg: N=46; Brussels: N=12.
In Limburg, the number of patients per doctor is not equally spread. However, we notice that mandatory
physicians (GHA) have a rather high number of patients (from 20 to 50). This is probably due to the fact that
they are in close contact with the MSOC in Limburg, assisting a great number of patients with treatments of
substitution. The other doctors have relatively few patients (1 to 4). Of course there are always exceptions.
Concerning the substances, methadone comes in the first place, while Temgesic (buprenorphine) is also
prescribed but to a smaller extent. A striking fact is that mandatory physicians prescribe GHA both Codicontin
and Temgesic, while other physicians rarely or never prescribe Condicontin.
The contact frequency varies between GHA and “ usual” practitioner. Practitioners see their patients more
often (1 x week) than the GHA (1 x two weeks). The reason for this difference is that the GHA consult almost
exclusively in the MSOC, where doctors work in shifts.
Just as the “usual” doctors in Limburg, the responding doctors in Brussels have generally a small number of
patients (1 to 3), each exception is not taken into account (from 17,20 to 30 for one psysician). Even more than
in Limburg, the doctors involved consider methadone as the best substance. The contact with patients occurs
1x/week or 1x/two weeks, what we considered as a little bit less frequent than in Limburg.
Modalities
The GHA in Limburg seem to prescribe more easily long-term substitution medication than the “usual”
practitioner preferably applying short-term treatment of substitution. In general, the maintenance treatment
(unlimited duration) is the most frequently chosen modality (almost 75%), followed by the stricto sensu
substitution treatment (almost 68%). Being the less chosen modality, the degressive withdrawal still remains
applicable for more than 55% of the patients.
The respondents in Brussels acknowledge giving mostly treatments of substitution stricto sensu, and somewhat
less maintenance treatments. The modality of progressive “withdrawal” is being left aside; almost 2/3 of the
respondents explicitly admit no using this method.
A very important remark, confirmed in many conversations with practitioners and assisting staff, is that the
modality prescribed does not always match the daily reality. In the beginning of the treatment, the modality of
use is not even fully known; it only appears during the treatment and depends on the patient’s individuality and
its specific state. In case changes appear in the patient’s state, the modality can be adapted too during the
treatment.
Contact with specialized drug assistance centres
The situation in Limburg is simple: the GHA works together with the MSOC Limburg. The other physicians
can either keep connected to the MSOC of a residential drug-centre, or work “on their own”. According to the
responses of our survey, 12 of the 21 not mandatory physicians have, presently, no contact with drug
specialized centres; this is an impressive result. A priority for the second phase of the research is to have an
exhaustive conversation with these doctors.
Apparently, the physicians in Brussels do not make a clear difference between “institutions” and “network of
doctors”; both categories being referred to in the same manner. Furthermore, there are very little Dutch speaking
drug centres in Brussels, therefore Dutch-speaking doctors work together with French speaking doctors or
centres.
15
Survey
The last question of the survey concerned the opinion of the respondents about several controversial topics
(within the field of treatments of substitution). Separating respondents applying treatments of substitution and
respondents not (or not longer) applying treatments of substitution could not provide for significant differences.
A certain consensus was found among all physicians of Limburg on the following topics; ‘standard and central
registration, ‘compulsory support and training for physicians’ and ‘compulsory psychosocial follow-up of the
patient’. These topics where evaluated by everyone as (respectively) ‘very positive to ‘positive’. The topics on
‘reimbursement of Subutex and Naltrexon’ were considered favourable and almost as much respondents had “no
opinion” on this point.
The fact that these substances are almost unknown in the Flanders could account for this result, as some
physicians did specify and especially mentioned, “in the Flanders, buprenorphine is known us Temgesic”.
Opinions do vary on the topics of ‘medical prescription of heroin’: this is as well considered as favourable as
unfavourable, with a slight majority of unfavourable judgement for physicians applying treatments of
substitution and very negative position of physicians not (or no longer) applying treatments of substitution.
Could we conclude out of the category ‘no opinion” that some physicians dare not express their opinion on this
matter?
We could not forge an opinion over the physicians in Brussels considering the limited amount of respondents
and the fact that only half of them did not answer this question. The results are close to the results of Limburg,
except for topic on ‘medical prescription of heroine’ judged as slightly positive by physicians applying
treatments of substitution but as very unfavourable for physicians not applying treatments of substitution.
In short, for Brussels and Limburg, we can observe that all topics are rather positively considered, except for the
rather controversial topic of “medical prescription of heroin” mostly considered as not favourable except for
some exceptions, (among which physicians applying treatments of substitution).
5.2.
Qualitative evaluation of Focus groups and discussion groups
5.2.1.
Province of Hainaut and Brussels
5.2.1.1. Focus Groups with physicians applying treatments of substitution in private practices
4 Focus Groups (FG) took place in the frame of this research: 2 in Brussels, 2 in Charleroi. According to the
criteria of this methodology, the meetings were organised around open topics meant to lock out discussions and
gather every expressed opinion. This approach consisted in presenting the legal presentation of the treatments of
substitution and their technical modalities; for example: the list of eligible products for treatments of
substitution (methadone, buprenorphine…);

Conditions for prescribing and administrating the medication;

Registration of the treatments in conformity with the law and the protection of the privacy;

Number of patients per physician;

Follow-up of the treatment and training of the physician;

Relation of the doctor with a specialised centre or an assistance network3.
Globally, from an evaluation point of view, the situation of a physician applying a treatment of substitution in a
private practice is complex. First of all, a relatively important amount of physicians follow a small amount of
patients; there is a great disparity of subjects. Secondly, the restricted frame of a consultation, and it’s limited
duration (10 to 30 minutes) make impossible the use of specialised tools. Thirdly, a consultation by private
doctor is a closer therapeutic relationship: one goes to a family doctor, because he knows the patients sicknesses
and way of life, he is trusted by several members of the family, and guarantees a certain privacy.
3
Loi visant à la reconnaissance légale des traitements de substitution et modifiant la loi du 24 février 1921 concernant le
trafic des substances vénéneuses, soporifiques, stupéfiantes, désinfectantes ou antiseptiques, 22 août 2002, art. 2§4.
16
5.2.1.2. Discussion groups called "institutional intervision" with institutional staff members
The work of the” institutional intervision" has mostly been focused on the good follow up of the tests with the
questionnaires. During these discussion groups, participants have been able to express their opinion on the
relevance of the instruments used. They received some training over the use of the tools, brought out new ideas
about the improvement of the research process, proposed new tools and gave their opinion on the validity of
these tools and their use.
The approach of ‘institutional intervision’ is worked-out for ‘medium term’ periods (2 to 3 years). It is then that
it delivers it’s best results, namely in the process of matching the objectives of a team and the instruments to
reach them. At this stage, we observed the relative adequacy of the Quavisub questionnaire with the
preoccupations of the participants, and on the other hand, the relative inadequacy of the preoccupations of ASI
with the clinical work of the participants.
5.2.2. Province of Limburg and Brussels
Discussion groups of mandatory physicians in Limburg
The discussion groups with 16 mandatory physicians in Limburg added important extra information
considering the fact that, according to us, the pre-existing questionnaire TUF did not completely meet the
specific expectations of this research. During a first meeting, this group was asked to answer a closed
questionnaire – developed by the research team of the KU Leuven- . During the second meeting, open questions
will be asked on discussion themes and topics that will be brought up by researchers and people on the field.
The respondents have already +- 18 years of practice as practitioners and about 9 years the status of
‘mandatory physician’ (GHA). This system existed already before the MSOC started in 1997.
Diversity
After processing the collected data, the most important conclusion seemed to lie in the large (theoretical and
practical) differences in the treatments of substitution and all their aspects. This even more striking that the
respondents questioned the necessity of the questions, considering that “there were already guidelines from the
Conference on Consensus followed by all the actors involved’…
Afterwards, we discussed the principal findings of the first stage with a discussion group of 16 GHA of Limburg,
namely the results of the KULeuven questionnaire. All through these findings, it will be clear that the
application of treatments of substitution, even in region (province of Limburg), show large differences. We
could suppose that during the second phase of the research, this diversity will show up in other regions and even
to a larger extent. Checking this hypothesis will be an important mission within the second phase.
Objectives
On the contrary of our expectations (and the one of the respondents) there seems to be no agreement on the
objectives of the treatments of substitution. About the objectives and the importance, the answers are very
different. When three important objectives should be classified by order of importance, is gets even ambiguous;
more than half of the respondents gives as important objective “the improvement of the social and life
circumstances” (= harm reduction thinking). This, while simultaneously a fourth of the respondents chose as
number 1: “abstinence of illegal drugs” (= oriented towards immediate physical abstinence and later on
psychological).
Briefly, we cannot speak of a consensus on the objectives of treatments of substitution, except for the objective
of ‘improving the life circumstances and the social functioning of the patient’ that was considered as very
important by the large majority of the respondents.
Inclusion criteria
Another clear example of this diversity in the practical application of the treatments of substitution concerns the
criteria of access. We would expect little variation in the answers considering the fact that the Conference on
Consensus already set the criteria, the doctors answered in a very different way, namely concerning the failed
attempts of withdrawals and the number of years of dependence to opiates. All physicians apply controls of
urine.
To the question if these criteria should be less strictly applied for some sub-groups, the answer is clearly
negative. For HIV/Hepatitis patients, pregnant women the answers are again very divergent: one half declares
applying the rules less strictly for this group, the other half making no difference between this group and the
other patients.
17
Substitution means and doses
There is more clarity about the nature of treatment of substitution. Methadone remains the product of reference,
mentioned by all physicians; only a few mention buprenorfine or Codicontin. Concerning maximum doses the
answer is dual: one half of the respondents have a maximum dose, the other half doesn’t. The norm for the
maximal dose is >100mg/day (except in one case). The absolute maximum dose was 140 mg and had been
prescribed by only one physician. As previously mentioned, Methadone is almost always concerned; if we
consider the active file of patients of all the physicians, it appears that 90% of the patients following substitution
treatments received a medium dose of 21 to 60 mg/day.
Follow-up modalities of substitution treatment.
In this field, many important observations must be done:
- First, except for one physician, nobody sets a specific duration for substitution treatments.
- Concerning the modalities of the substitution treatments, maintenance treatments appears more relevant. A
large half of the respondents use this way of prescription. It obviously implies a variable duration of the
treatment of substitution
- Then, substitution treatment stricto sensu is applied to a fourth of the patients (2 to 5 years)
- Progressive withdrawal is rarely used. 10% of the patients received such treatments.
These observations are not surprising because patients concerned here are patients related to a MASS-MSOC.
Indeed, this service is supposed to function in agreement with the harm-reduction philosophy aiming at the
rehabilitation of the patient to the community.
Distribution and delivery of the substitution medication
The largest majority, i.e. 13 physicians (80%), ‘always’ or ‘nearly always’ prescribes in a MASS -MSOC.
Nevertheless, it is remarkable that half of the physicians admit to prescribe ‘sometimes’ in private practice.
25% of the physicians follow their patients in private practice but essentially for other medical reasons than the
prescription of substitution treatments. An appreciable group of respondents (1/5 of the 16 physicians) ‘never’
prescribes in private practice.
Evaluation of substitution treatments
At last, a brief explanation about the follow-up of the patients in substitution treatments:
- A ‘plan’ is worked-out for 80% of the patients, in the very beginning of the follow-up, either by the
MASS-MSOC (7/16) either by the GHA in accordance with the MASS-MSOC.
- The patient is also assessed during the follow-up of substitution treatment. Only 2 physicians mention doing
it only ‘sometimes’. That happens during the meetings of intervisions with all the actors involved in a
patient’s treatment.
- At the end of a treatment a final success assessment is established, allowing us to look deeper into the
criteria that have been used. But, the different terminology used and the various answers given do not
allow us to develop here a detailed comment on this point. We refer here to the general report. This topic
will be developed during the second panel of discussion.
5.3.
Other existing questionnaires
During the operations, the researchers did also wonder about the existence and the relevance of alternative
questionnaires, more adapted to the reality on the field. These alternative questionnaires have, however, been
less studied and commented. The analysis criteria of these questionnaires are the same than the one formerly
mentioned: objectives of the treatments established by law and the recommendations of the Conference on
Consensus.
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5.3.1. Evolutox
This short questionnaire (19 items) has been established by the Network of assistance to the drug-addicted and
has been subjected to a research contract of the FNRS and the CoCoF (Ledoux Y et al, 1993, Remy C, 1995 et
1997). As it name says, it is meant to evaluate the evolution of a drug-addicted treated by treatments of
substitution.
The 19 items deal with the following dimensions:
1. Products: 3 items concern the frequency of use of toxic products and the dosage of the
treatment of substitution.
2. Severity Index:
a. Factor of exclusion composed of 5 items; project of life, work, self-sufficiency, look,
and identification to drug-addicted.
b. Factor of deviances composed of 3 items delinquency, deal and legal situation
3. Health condition: 3 items explore the existence of medical pathology treated or not, the
intensity of depressive and anxiety states.
4. Social aspects: 2 items take into account the social situation, on the one hand, and the selfsufficiency in the daily situations, on the other hand.
5. Therapeutic work: one item evaluates the contract with the physician and the infringements,
the other evaluates self-criticism of the patient toward it’s own addiction.
.
During the first contact, the physician fills in an anamnestic form on drug-addiction and the uses of the products
and the patient fills in a questionnaire self-administered focussing on his life context and his expectations.
All the items are rated from 0 to 4 and represent a page recto-verso. They have to be completed every three
months from the beginning of the treatment. The necessary time to fill it in is short and compatible with the
medical practice in a private practice. The uniformity of the gap of each item, all identically rated, makes the
processing and the statistical analysis of the data easier.
5.3.2. Minimum Addiction Data (RTM) (Résumé Toxicomanies Minimum)
The Minimum Addiction Data (Résumé Toxicomanies Minimum; RTM) is a module integrated in the Minimum
Psychiatric Data (Résumé Psychiatrique Minimum; RPM) adapted to the specificities of hospitalised drug-users.
This module has been developed by professionals on the field and is compatible to the European standards and
completed with clinical items. Furthermore, a users manual is available. Because of administrative difficulties
concerning the RPM, the RTM, although ready for use, has not yet been fully applied until today (Bergeret I et
al, 1999 et 2001).
5.3.3. KULeuven – questionnaire for physicians about treatments of substitution
This experimental questionnaire is meant to approach globally the patients of the general practitioners. It is
divided in 8 sections:
1. Identification of the physician
2. Goals pursued for the treatments of substitution
3. Patient’s inclusion or exclusion criteria
4. Substitution products used and dosage
5. Modalities of treatments of substitution
6. Prescribing and distributing treatments of substitution
7. Evaluation
8. Number of patients in treatment.
Globally, this questionnaire is clear and easy to fill in. It requires no particular figures but rather global
estimations (for example percentage of patients under methadone). It explores all essential aspects
characterising treatments of substitution.
However, in the construction of the scales we noticed some metrological defaults. The gap of the scales varies,
what makes statistical progress more difficult. Sometimes, the answer « medium » is not in the middle of the
scale, what will give this answer a positive weight during the statistical analysis instead of a neutral one. The
order of quotation is not homogenous (in some scales “always” corresponds to the maximum quotation, in
another case, to the minimum) with no apparent reason. Until today, as far as we know, this experimental
questionnaire has been the object of a validation study (validity of construct, fidelity…).
With some metric adaptation, this questionnaire can be interesting.
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5.3.4. Mini-Questionnaire of the Medical-House
During the meetings with the doctors of the medical house, they expressed the wish of having a simple and rapid
instrument of work at their disposal, adapted to the reality of the medical practice of a consultation. A draft was
developed meeting the following demands:
 One page questionnaire (easy and quick)
 Preserve the evaluation scale of ASI (4 severity and importance intervals for the patient)
 Include, above all, the different aspects of the multiple problematic items of drug-addicted patients.
Of course, this document is, for the time being, only a draft and has not been validated.
5.3.5. Questionnaire for Methadone clients in the Netherlands (MCN)
F.M.H.M. Driessen has used this questionnaire in the Netherlands (Driessen 1992). It is specifically meant for
treatments of substitution with methadone. Reading the questionnaire, we can identify the following dimensions:
1. Social identification of the patient
2. Drug use and methadone
3. Physical Health
4. Mental Health
5. Justice
6. Work and education
7. Anamneses over the family and childhood
8. Assistance by professionals
Le MCN contains 67 questions in a row, without subdivisions, and fastidious presentation. The questions asked
are very similar to the ASI. Many items are dichotomised, a certain amount are parametric. Regrettably, the rated
items do not systematically follow the same gap, what makes statistical work more difficult and limits the usable
methods. Just as the ASI, this questionnaire explores scarcely the positive aspects of the life of a drug addicted.
The material life conditions, the social and affective life of the patient are barely approached. Few items are
adaptable in function of the follow-up and changes of the patient, but only reveal the general profile of the
patient. Compared to Evolutox, this questionnaire does not explore the therapeutic alliance, the life projects, the
insight and identifications to the drug addicted person. Also, it does not reveal the severity index and, as far as
we know, does not develop composite scores. Furthermore, this questionnaire does not explore the objectives of
treatments of substitution.
Finally, we did find any study on the validity and metric values of this questionnaire.
5.3.6. Questionnaire about methadone delivery in the Netherlands (MVN)
This questionnaire has been used in the Netherlands by F.M.H.M. Driessen (1990). Like the TUF, this
questionnaire, aims at developing an institution profile.
This questionnaire is very detailed and contains 111 items describing of the activity and the organisation of an
institution.
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6.
Discussion
All along this research called “Substitution treatment in Belgium- Development of a model for evaluation of
the different types of services and of patients” we have chosen to refer, on the one hand, on the Law’s
regulations, and, on the other hand, to the findings of the Consensus Conference and its follow-up.
6.1.
Critical Discussion and quantitative analysis
Three tools were used for the quantitative analysis. The Addiction Severity Index has as objective to determine
the needs perceived during the treatment and set a profile of the context of drug-addiction. The Quavisub, on
the other hand, evaluates essentially the subjective and objective Quality of Life as well as the satisfaction
created by the use of addictive products or addictive behaviour. The TUF is a descriptive tool allowing to set a
general profile of the institution. In order to evaluate the feasibility and the relevance of the use of these tools
on a daily basis each institution has implemented themselves these different instruments.
6.1.1.The Addiction Severity Index
The ASI has already been used in more than a thousand places in the world. This means that it can be used as
well for drug-addicted as for alcoholic patients provided some slight formal modifications. Reading the article
published on the ASI, it appears however, that this tool is mostly used in detoxication residential centres or
hospitals where the patients are fully evaluated before their admission. This is not the context of this study.
The practitioners who processed the ASI acknowledge the relevance of the domains explored, and appreciate the
fact that it broadens the scope of reflexion to all the life domains of the drug addicted. However, they regret its
heaviness, the disproportion of the items about the past compared to the items on the actual life, the accent on the
severity of the problems without paying much attention to the positive factors. Concerning the processing of the
items, it seems very complex and requires not only regular checks in the manuals but also two full certified
training days.
The statistical validity of the alpha coefficient of Cronbach and the composite index on « drugs », is not
considered as extraordinary by the international literature, and score clearly bad in our sample. The gaps of the
items varies in numerous questions, what makes the reading more complex for the researcher.
For all these reasons, it seems, at the end of this study, that the ASI, though gathering massive information on the
life domains of the drug addicted, is not the most appropriate questionnaire in the context of delivering
treatments of substitution in Belgium; it remains however an interesting tool for specialised care-giving centres,
for evaluations and adaptations.
6.1.2.The Quavisub
More than 50 studies have already evaluated the Quavisub in France, Belgium, Canada, and USA. This
questionnaire explores as well the objective as the subjective Quality of Life. It contains several tools, largely
used, in particular by the SLDS of Baker and Intigliata. It is presented as a self-administered questionnaire,
taking about twenty minutes, the processing time being of 10 minutes. The processing has presented no major
problem to the MASS of Charleroi who had them filled in in the waiting rooms. It has been less filled in the
medical houses, mainly because patients forgot to be return then on the next consultation. In this context, it
would be interesting to have a shorter version at disposal, in order to be able to fill it in in the waiting room.
As such, Quavisub is not a specific tool. It can also be applied to healthy persons, and the authors have
demonstrated that the process of evaluating quality of life is based on the same criteria by healthy patients than
patients. It sets priority on the subjective part of the person, while taking into account the objective context. He
has also a satisfaction scale on addictive products and behaviour. The physicians appreciated the philosophy of
the questionnaire, closer to their clinical preoccupations, and the fact that is deals with life domain that can be
improved.
Statistically speaking, its validity is very satisfactory whatever the criteria. Its processing is easier due to the
availability of a software calculating automatically the composite scores according to the same gaps. It is also
possible to print out a double report: one for the patient (text), and one for the physician (graphical form). It
requires no particular training for the processing, but demands refreshing one’s knowledge for the reading of the
graphics represented with standard gaps. Different versions of Quavisub exist.
In case of joint use with the ASI, the short version is recommended. For the follow up of this study it is
recommended to use the medium version, with the perception of sensations scale during the use of products or
during an addictive behaviour.
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6.1.3. The TUF
The TUF is a descriptive tool aiming at setting an institutional profile. It is an experimental tool proposed by the
Greek Focal Point of Lisbon. The small amount of institutions studied does not allow us to take position about its
discriminating value and its particular relevance. It could easily be replaced by another tool if this later seemed
more adequate.
6.2.
Quantitative analysis
6.2.1.
Province of Hainaut and Brussels (French speaking)
The quantitative approach has followed two different ways: first the Focus Groups (FG) were used as brainstorming with a group of physicians applying the treatments of substitution in private practices in order to bring
out as much ideas as possible on the follow up modalities of the treatments and the feasibility of implementing
an evaluation system adapted to this specific practice. Several hypotheses have been expressed and propositions
have been made about tools structure.
On the other hand, the ‘institutional intervision’ approach has been used in institutions in order to obtain the
emergence of a consensus about the use of products. Apart from technical advice over the questionnaires, the
principal interest of these qualitative methods has been to show the great variety of the type of assistance given
with the same instruments: medical prescription and treatments of substitution. At this stage, it appears that a
reliable and long-term clinical evaluation does not mean stopping the inventory of all the different practices that
reflect all the underlying representations and philosophies of assistance
6.3. Alternative Questionnaires
Several alternative questionnaires have been analysed on their face validity. (Do they make it possible to meet
the criteria of the Law and the Conference on Consensus? Are they well constructed? Are they specific? Can
they be used as a routine in a daily medical reality and in particular in the Belgian context of delivering
ambulatory treatments of substitution? Are they adapting to different philosophies of treatment and assistance?
Do they explore the primary objectives of the treatment?)


Only one questionnaire meets the above mentioned general set of criteria: the Evolutox.
Two questionnaires do not deserve being rejected for their short size: the « MiniQuestionnaire of the Medical House » and the « KULeuven – questionnaire for physicians on
substitution treatments ».
 One questionnaire does not meet the selection criteria: « questionnaire for methadone clients
in the Netherlands (MCN) ». One questionnaire could replace the TUF: the « Questionnaire
about methadone delivery in the Netherlands (MVN) ».
Important: None of these questionnaires have mentioned the expected changes of the patients by the treatment.
These are esssential to evaluate the institution (or the physician in private practice) in the given domains and
observe the expected changes in the patient. Adding an item “expected changes during the treatment” or develop
focus groups within the institutions could make the difference.
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7.
Propositions and conclusions
7.1. Final Questionnaire
The authors propose two kinds of questionnaires:
 An extra-short questionnaire inspired from the « Mini-Questionnaire of the Medical House » and of
the « KULeuven – questionnaire for physicians concerning substitution treatments » that could fit
in one page and could be filled in after a consultation in less than 3 minutes. This questionnaire has still
to be validated.
 A standard questionnaire containing the following domains:
 Products: frequency of use of dugs and dosage of the treatment of substitution
 Severity index
 Exclusion – self-sufficiency
 Social deviance and legal aspects
 Physical and mental health including HIV and hepatitis
 Social situation
 Evolution of the therapeutic alliance
 Life events and anamnestic elements
 Subjective and objective Quality of Life
 Scale of perception of sensations during the use of a substance or during an addictive
behaviour
7.2. Recommendations
The integration of these questionnaires in a ‘research-action’ as defined in the former study concerning the
MASS (Pelc I et al, 2001) is essential. They have to be implemented by the institutions together with a
follow up, within the process of reflexion over the objectives of the treatment. Therefore it is necessary to
have:
1. Immediate feedback about the questionnaire (as a report or understandable graphics). The easiest way
would be to deliver a software instrument.
2. A profile of the analysis of their processing, either as a written report, either (better) as a meeting
between the institutions and the entity centralising information,
3. A possibility for the clinicians to express the gap between the analysis and their preoccupations on the
field, that would be taken into account,
4. A questionnaire that would not be frozen, making it possible to add evaluations about the objectives of
interests points (as in the RPM),
5. A collection of information on qualitative dimensions namely expected changes and therapeutic
relations; this collection being a mean to think about the practices and not an objective as such.
7.3. Conclusions
The general results of this first study are as follows:
1. In Belgium, the treatments of substitution are correctly framed by the recommendations of goodpractices but applied in very different environments of services and medical assistance with, in each
cases different objectives (thus different meanings)
2. Except for specialised institutions in this field, the number of practitioners applying the method is, on
the one hand, limited and on the other hand, the number of patients assisted by each of them is also
limited
3. Until today, there is no administrative frame for the systematic evaluation of the treatments and uses in
this field. Furthermore, the requests of research teams in the field of drugs, are nowadays very
important and therefore represent a considerable limitation for the teams on the field to participate to
such evaluation, except if we consider the possibility of an progressive 'action-research’ during the
study allowing the constant and efficient integration of the research team with the people on the field.
4. According to the former observation, it is interesting at this stage, to propose two types of tools which
characteristics described above;
5. Finally, such research can only happen within an ‘action-research’, thanks to its great adaptation
capacity in its methodology; and of course, in the frame of precise definitions of the objectives and redefined studies.
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