19 Management of the project
This part of the report follows the procedure of the project as it is grounded in the proposal of the project – “description of the action”, Annex I of the contract. The paragraphs follow the 7 work packages and the corresponding 8 deliverables as they are elaborated in the proposal.
19.2 Inventory of good practice and their evidence (workpackage 4)
„Development of the methodological procedure“ (deliverable 1)
Objective was to develop an unified methodological procedure for the collection of evidence and the presentation of guidance.
Therefore an procedures was developed (and corresponding instruments) that should allow the evaluation of the dimensions, standards and assessment levels of the relevant interventions:
• Dimensions are: Approach, context, duration, staff, client groups, eligibility, inclusion and exclusion criteria, treatment access to service, referral pathways, integrated care pathways
• Standards are: management standards, commissioning standards, responsibilities; performance/outcome monitoring; seamless provision of services and support from one setting to the other (e.g. community – prisons/hospitals, psychiatry), care coordination, departure planning, monitoring
• Assessment levels are: process-management, phases of treatment, performance/outcome monitoring. For identification of evidence a search strategy in Europe and on the level of the member States has been developed. For data extraction a “review protocol” for data extraction from studies are presented. A corresponding data base with the possibility of online data entry for partners has been established (see below).
„Implementation of methodological procedure“ (deliveralbe 2)
Implementation of the methodological procedures with the associated partners has been realised. Corrections and specification of the procedures took place in dialogue between Hamburg and the partners. The search of interventions in drug treatment in all European regions through the associated partners for the different aspects of drug treatment (treatment modalities, system level, cross-cutting issues) had been implemented.
The project members started the collection of information, data and literature about the evidence and effectiveness of these interventions through searching in national and international databases and through contacts to experts in the area of drug treatment. The following relevant process issues (as to methodological procedures) have been implemented:
• Main aspects of the methodology (collection of evidence)
• Elaboration and agreement about data extraction (for evidence)
• Implementation of a central database
• Identification of the “most relevant” studies on drug treatment interventions for the preparation of draft protocols (detailed problems see below)
• Agreement about an unified structure of the drafts (treatment improvement protocols)
• Method for development of standards for treatment interventions based on evidence Further methodological aspects of the project are covered in the next chapters.
Handling of methodological problems
Problems of identification of evidence In identifying the additional evidence – not represented in international scientific databases – on the level of the Member States practical problems on the background of limited resources arrived. The problem was addressed by clarification of the search strategy (evidence search) between the partners (in the Kick-off meeting – August 2007). The result was a stepwise procedure and a hierarchy with regard to a search strategy (How to come to the „most relevant“ regional evidence?): Step 1: Through central search identified papers, that are reassigned to partners (This studies should be integrated in an European evidence report.) Step 2: Search in (regional) databases (based on a centrals search terms, which focus on the interesting interventions) (The general search term has been developed in Hamburg and adopted by the partners) Step 3: Expert based (research institutes, public health experts) collection of the additional/grey literature.
Adoption of data extraction form and the database The main aspects of the introduced data extraction are confirmed by the practical experience of the partners. Sometimes, the identification and collection of the “most relevant” interventions/studies/treatment modalities was found to be difficult and required a consultation with further experts. Furthermore, some difficulties raised due to the differentiated extraction sheets, which occupy sometimes much time. In general, the process of identification and especially the assessment of interventions requires in some cases more time as expected. Especially the sheets for the assessment of study quality are difficult to answer on the basis of a single publication. Methodological problems of the data extraction form (and the database) came up with the first experiences. Problems are discussed on the Kick-up meeting based on practical examples. This meeting had a training aspect as regard to the extraction process. A common problem (especially in the additional grey literature) was, that the studies had seldom information as to the differentiated aspects of the data extraction. Also most of these studies could not reach the quality that a differentiated quality assessment (conceptualised for the level of RCTs) was applicable. A revision process of the database refers to cancellation of single items. Problems of the Web-based database in (limited time of access) are only solved partly during the project time; one solution was to make the database (FilemakerPro) physically available in the centres.
“Reviews about interventions in drug treatment and their effectiveness“ (deliverable 3)
In the project regional search strategies have been realised by partners, and the studies are regionally assessed. So the origin of special evidence is comprehensible. But the elaboration of systematic regional reviews (for different interventions) and a special presentation of national evidence (evidence by member states) doesn’t makes sense. As a consequence the evidence, that was identified in this project is presented in two corresponding ways:
• European evidence as to different interventions; the report on evidence took place in a special section (see part 5.1) and in the evidence parts of the protocols (see part 6);
• Additional European evidence (not presented in international journals and in English language) is considered (if additional information are delivered) also in the protocols (part 6). In part 5.2 studies with their content and origin a described.
19.3 Drafts of good practice protocols (workpackage 5)
The general aim was to produce drafts for “good practice protocols” for different treatment modalities/interventions, for so called “cross cutting” issues, and also for the “system aspects” of drug treatment All partners worked on basis of the reviews of good practice, evidence of effectiveness for drug treatment in the EU-Member states:
• International evidence,
• European evidence (published in English language)
• European evidence (available in the form of scientific reports, published in national scientific journals and grey literature)
Selection process – „Drafts of models of good practice guidance“ (deliverable 4)
The selection process of the (most) relevant areas of interventions is corresponding to the overall objective and the target groups of the moretreat-project:
• The guidelines serve from a public health perspective for implementation of different interventions according to evidence of effectiveness (for every intervention according to the hierarchy of aims of treatment).
• • The guidance/guidelines as the products of the project are directed to public health authorities, providers and different groups of professionals. (That means: Main tasks are not directed to internal protocols for special treatment aspects – as dose schemes for different medications for example, but to general aspects of implementation).
• On this background the project selected the following most relevant areas for “treatment improvement protocols” based on evidence and the responsibilities for drafts:
• Brief intervention and brief therapies for drug treatment TUD – Dresden
• Enhancing motivation for change in drug treatment ITACA – Rome
• Interventions in blood-borne diseases“ – needle exchange, prevention, testing advice, Injection rooms CIAR – Hamburg
• Maintenance treatment (different medications) MUM – Vienna
• Psychosocial interventions SU – Stockholm
• Detoxification KLC-NAC – London
• Treatment in Criminal Justice System IPiN – Warsaw
• Comorbid mental health disorder – drug treatment with co-occuring disorders CIAR – Hamburg
• (Drug treatment in primary care TUD – Dresden)
• Treatment for stimulant use disorders KLC-NAC – London
• (Treatment for multi-substance users ITACA – Rome)
• Pregnancy and parenting in drug treatment MUW – Vienna
• (Inpatient and residential treatment SU – Stockholm)
• System IPiN – Warsaw Three of this in the beginning of the project planned protocols have been cancelled (protocols in brackets) for different reasons:
• “Drug treatment in primary care” is integrated with the protocol on “Brief intervention and brief therapies for drug treatment” for reasons of overlapping. The most important setting for brief interventions is primary care and on the other hand: in primary care brief interventions are the dominant interventions;
• “Treatment for multi-substance users” has been cancelled because the project could not find enough specific evidence for a protocol. The main issues of treatment for “multi-substance” use, that is the rule rather than the exception is considered in the guidance for treatment of opioid-addicts, co-occuring disorders, and harm-reduction.
• The issue of “Inpatient and residential treatment” has been integrated as a special chapter in the guidance for “psychosocial interventions”.
Structure of the guidelines/protocols
The project discussed a common structure for the drafts (“treatment improvement protocols/good practice guidelines” for different areas of drug treatment interventions. The starting point for an unified structure of the drafts had been: Definition, aims and objectives, research evidence, access, assessment, process-management, standards, performance and outcome monitoring. As the general structure was worked out:
A. Definition & objectives
• Definition or problem definition Context, Philosophy and approach, Location, Programme duration, Staffing/Competencies
• Aims & objectives Aims of treatment/of the intervention, Client groups served, Eligibility, Priority groups, Exclusion (contraindication)
• General description of the current situation with regard to the available data
• Short description of the main outcomes all studies (Structure of evidence report depends on the specific intervention; international and european evidence is reported separetely – if adaquate)
Structure of recommendations differs for interventions. If adequate it contains the following aspects
• Access – Access to the service, Referral pathways and relevant pathways of care, Integrated Care Pathways
• Assessment (level, assessment dimensions)
• Treatment phases, -processes, standards – co-ordination, planning and review
• Core management standards – Commissioning standards (detailed standards or schemes/protocols), Clinical management and responsibility
Modifications of structure for guidelines are decided for treatment/interventions for special groups (for example stimulant users, co-morbidity, pregnancy, or prison) General structure (for special groups or cross cutting issues) is:
For point A. (Definition & objectives)
• Definition of the special group
• Epidemiology, Prevalence, Nature and extent (particular needs)
For point B. (Evidence base)
• Service accessibility and service utilisation
• Effectiveness of treatment and interventions
For point C (Recommendations)
Structure of recommendations differs for special groups or issue.
These structures are relevant also for the “fact sheets” or short versions of the guidelines.
“Fact sheets” of all “treatment improvement guidelines”
Short versions (“Fact sheets”) of the guidelines (three to four pages) were produced and translated to French and German for easement of dissemination.
19.4 Organisation and realisation of the consensus process and finalisation of the good practice (workpackage 6)
Objective and stages as to the proposal were:
• Realisation of formal consensus process (based on the drafts) via Delphi procedure based on nominal group technique
• Organisation of a conferences in Hamburg (3 days) to discuss and resolve open questions in the draft protocols
• Finalisation of “good practice protocols” by all partners (full version)
„Realisation of the consensus process“ (deliverable 5)
Preparation of consensus building Preparation of the consensus process in the project implied:
• Selection of experts in different areas of treatment
• Allocation of drafts to the planned consensus conference
• • Connect drafts of close-by areas or levels of treatment to associated partners, experts and collaborative partners The process of achieving consensus had been carried out through:
• Draft protocols will be sent to all involved partners with a short questionnaire (not realised) with closed and open questions, which highlight potential barriers to consensus.
• The questionnaires will be analysed by experienced experts.
• All points potentially not consensual will be collected and discussed in the consensus conference.
• In case of divergent opinions regarding relevant issues a consensus document will be prepared including both, the opinion of the majority of experts as well as the opinion of the minority of experts.
The final documents (good practice protocols) should circulate one last time after the conference for last input.
In principle this procedure – the steps from drafts, reviews by experts, collection of open questions, discussion and revised versions with the same circuit again – has been realised. But as to a time lag in preparation for most of the draft this process was not as systematic as planned and not harmonised in front of the consensus conference. Especially after the conference several experts were involved to discuss the recommendations of the final version of the treatment improvement guidelines.
The consensus conference has been realised in the last week of May, 2008 in Hamburg. Participants were the partners of the projects and some additional experts. As many of the draft had been on an elemental stage the formal consensus process was not possible at the conference. So the conference focussed on principal methodological questions as the evidence based interventions. Broad discussed was the question how guidelines are based on evidence and how they are systematically connected. Consensus about the structure and the scope of the intended guidelines had been achieved. The conference came to the conclusion that the project should not aim to “protocols” in a strict sense, if a protocol refers to a mandatory procedure for a special treatment. So to products of the project are presented as “treatment improvement guidelines”. This title signalise that improvement of the different areas of drug treatment is a process and that the guidelines should be renewed periodically if experience and knowledge is expanded.
“Good practice protocols” (deliverable 7)
In the period after the consensus conference:
• The drafts are revised
• Send to internal and external reviewers
• Have been summarised in an additional short version (translated) and
• are presented in their final version (final report).
19.5 Proposal of a system (workpackage 7)
Aim was a proposal for the improvement of exchange of “good practice” in drug treatment on an European level. The proposal should consider existing platforms (especially EMCDDA plans) and clarify the connecting with national platforms in the member states (existing official platform for guidelines, exchange of good practice, improvement of treatment in Public Health areas).
„Proposal for a system of regular exchange of good practice guidance in drug treatment“ (deliverable 6)
Based on an investigation of existing European platforms and the situation in Member states (in cooperation with the EMCDDA) a proposal for improvement in the area of development and dissemination of good practice in Europe has been presented (see part 7).
19.6 Dissemination of results (workpackage 2)
Aims as to the proposal were
• Dissemination of protocols of good practice in drug treatment to all member states in Europe
• Dissemination of all protocols of the project to all relevant networks, services and organisations
• • Dissemination of the final report to support public health authorities and drug
• treatment commissioners in the member states Dissemination of the project results is based on the following deliveries:
• “Evidence reports” (revised versions) (deliverable 3)
• “Good practice protocols” (deliverable 7) – in short and comprehensive versions
• “Final report“ (deliverable 8) In the dissemination of the results of the project there is a time lag based on the delay in the completion of the drafts. Dissemination of the guidelines, the fact sheets and the evidence reports to networks on national and European level is ongoing. Publications of parts of the report are in preparation. In the focus of attention is the presentation (of different parts of the project results) in sections of the EMCDDA:
• evidence reports,
• guidelines/guidance for different interventions,
• special activities with the fact sheets.
19.7 Evaluation and quality assurance (workpackage 3)
The aims of the evaluation progress were
• to ensure the methodological procedure of the project,
• to ensure the compliance with the detailed/structured workplan (related to the time schedule, results, deliverables),
• to assure the quality of the work progress by the associated partners.
• Reviews of good practice and evidence for different drug treatment intervention modalities and their effectiveness,
• Good practice protocols for drug treatment interventions in Europe,
• A final report on different “good practice guidance” for drug treatment,
• • A proposal for establishing a platform for guidance for treatment on a European level that serves a continued improvement of drug treatment in the member states (sustainability).
• Main indicators for the progress of the project chosen in the proposal were. (The project results as to indicators have been reported in the chapters before; here the results are summarised.)
• Established methodological procedure Result: has been realised (with some revisions); see details before.
• Regional reviews about interventions in drug treatment and their effectiveness Result: Delivered are in this report reviews about the international and European evidence as to different pharmacological and psychosocial drug treatment interventions;
• Drafts of models of good practice (approx. 15) Result: These draft have been delivered.
• Results of the consensus panels based on evaluated findings of the evidence reviews Result: A formal consensus process was not realised; this for the development of guidelines relevant process need more time as was available in the frame of the project; for the drafts was a review process organised.
• Proposal for a system of dissemination of good-practice guidance for drug treatment Result: As during the project the installation of a “best-practice portal” under the head of the EMCDDA came to a decision, the main question for the moretreat project changed to recommendations for improvement of the platform.
• Good practice protocols (approx. 15) Result: This report contains 11 guidelines for treatment improvement; 4 papers have been canceled; their results are partly integrated in the elaborated guidelines.
• Final report, printed in 90 copies, PDFs dissemination via internet/Email Result: As the report is too comprehensive a printed version has been quitted; the whole report will be send by a PDF-document; the most relevant products – short versions of the guidelines (fact sheets) in English, French and German, the full guidelines and der evidence reports are presented in different networks and used for scientific publication.
• Database via EMCDDA (e.g. EDDRA) and 150 daily visits Result: The basis for this aim of the project has been produced. For realisation more time is needed. In the project a regular controlling of the progress as to the named indicators had been realised by the responsible partner (TUD, Dresden). The situation was reported periodically to the coordinating center. A interim evaluation of the situation of the project has been compiled for the interim report.
Evaluation follows the expected results of the whole project:
19.8 Coordination (workpackage 1)
Main components of coordination had been:
• Implementation of an intranet platform to exchange information between partners Result: A regular exchange by internet had been assured. The database for data entry of regional evidence (online available for every partner keyword protected) has been implemented.
• Control timetable of the project in regular contact with the partners Result: The timetable has been controlled regular by the coordinating center in cooperation with TUD that was responsible for evaluation. Time lags (for example in drafting and the consensus conference) are reported above.
• • Coordination of exchange from results (reviews, drafts) between the associated
• partners Result: Reviews and in between results of partners are disseminated in time and available for all partners.
• Collecting results from partners (regarding research protocol) Result: The results of the review process are integrated in an online database and in (for the different interventions) in the evidence parts of the drafts.
• • Coordination of the steering committee; continuous information of the committee as
• basis for their periodical assess of the quality Result: The steering committee has been informed about the progress of the project regularly. At critical points of the project there has been direct contact with the committee.
• Planning of expert meetings and consensus processes/conference Result: Has been realised. For detailed information as to problems in the concensus process see above.
• Adaptation of the results of the process evaluation Result: The report about process evaluation was presented for the interim report. Consequences were integrated in the following procedures of the project.
• Dissemination of the good practice protocols and the final report Result: As we had a time lag in the production of the main results of the project (guidelines – the full and short version) the dissemination of results has started jet. The main tasks for dissemination will follow after the time period of the project.
• • Report of the evaluation of quality insurance process of the project (interim process
• report) Result: Results have been integrated in the interim report.
• Compiling Final Report Result: Has been realised in the timeframe of the project.
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