Cohort
The SAMMSU Cohort is established as an open cohort aiming at the inclusion of more than 60% of current or past substance users in the participating centres. National coverage and representativeness of data will be guaranteed by inclusion of centres from all parts of Switzerland (Ticino, French- and German-speaking Switzerland) and the inclusion of both centralized and decentralized settings. Centres providing opioid substitution together with integrated somatic care are specialized in addiction medicine and usually have a high retention rate, allowing for sufficient continuity and thereby validity of the collected data.
Longitudinal data collection is performed at an annual basis, including the input of all relevant information that was collected during regular management throughout the observation period. Patients lost to follow-up can re-enter the cohort at any time whenever they continue medical treatment in any of the participating centres.
Database
The central database is maintained by the informatics division of the CTU at the University Basel. It is web-based and has been constructed using SecuTrial®. Clinical and laboratory data are entered by all participating centres in an online data entry system.
Data entry starts in the second half of 2014.
Participating centres
In the first phase, seven major substitution centres will start to enrol patients: Arud Zurich, Basel, Bern, St. Gallen, and Aarau followed with some delay by Lausanne, Lugano and Geneva.
Eligibility criteria
All patients registered in an opioid substitution program for at least one day, who are older than 18 years and who give written informed consent to participate will be included in the study.
Data collection
At baseline and subsequently at yearly intervals, a set of socio-demographic and medical data will be collected, including drug use/risk behaviour, comorbidities, medication, vaccinations and laboratory data (e-CRF).
Sample repository
Due to financial restrictions and to increase feasibility/acceptability (low-threshold approach), no sample repository for the collection of biological fluids or tissue is planned. However, participants are asked for permission to use stored blood samples or other biological samples that have been left over and stored after an individual diagnostic procedure (e.g. use of liver biopsy samples to perform an additional staining technology).
Data analysis
The full data set can be used in an analysis of a specific project. However, on-going standard analysis of data will include a full description of the population in order to optimise the medical management at the participating centres. The following list of routine analyses is planned:
· The changing demographics of PWUD attending opioid substitution programmes in Switzerland
· Changing trends in the use of illicit and recreational drugs
· The increasing burden of various somatic and psychiatric diseases (prevalence, incidence, hospitalisations) in PWUD in Switzerland
· The prevalence, incidence as well as need of and access to treatment of various diseases (e.g. hepatitis C) in PWUD
- to influence public health decisions on the allocation of resources, and
- to evaluate the efficacy and cost-effectiveness of prevention measures (e.g. the reduction of HCV community viral load by increased HCV treatment up-take)
· The barriers to treatment and outcome for various diseases (e.g. hepatitis C) with the aim to develop strategies to facilitate treatment access and optimise treatment for PWUD
· The quality of care (national and international benchmarking)
Acknowledgement
We thank Dr. Mathieu Rougemont for his input and work allowing the start of the cohort at the HUG, Geneva.
Ethical approval
The SAMMSU Cohort Protocol has been approved by the following ethics commissions:
St. Gallen (Leading ethics commission, Principal Investigator: Andrea Bregenzer)
Bern
Geneva
North West and Central Switzerland
Ticino
Vaud
Zurich
The SAMMSU Cohort is established as an open cohort aiming at the inclusion of more than 60% of current or past substance users in the participating centres. National coverage and representativeness of data will be guaranteed by inclusion of centres from all parts of Switzerland (Ticino, French- and German-speaking Switzerland) and the inclusion of both centralized and decentralized settings. Centres providing opioid substitution together with integrated somatic care are specialized in addiction medicine and usually have a high retention rate, allowing for sufficient continuity and thereby validity of the collected data.
Longitudinal data collection is performed at an annual basis, including the input of all relevant information that was collected during regular management throughout the observation period. Patients lost to follow-up can re-enter the cohort at any time whenever they continue medical treatment in any of the participating centres.
Database
The central database is maintained by the informatics division of the CTU at the University Basel. It is web-based and has been constructed using SecuTrial®. Clinical and laboratory data are entered by all participating centres in an online data entry system.
Data entry starts in the second half of 2014.
Participating centres
In the first phase, seven major substitution centres will start to enrol patients: Arud Zurich, Basel, Bern, St. Gallen, and Aarau followed with some delay by Lausanne, Lugano and Geneva.
Eligibility criteria
All patients registered in an opioid substitution program for at least one day, who are older than 18 years and who give written informed consent to participate will be included in the study.
Data collection
At baseline and subsequently at yearly intervals, a set of socio-demographic and medical data will be collected, including drug use/risk behaviour, comorbidities, medication, vaccinations and laboratory data (e-CRF).
Sample repository
Due to financial restrictions and to increase feasibility/acceptability (low-threshold approach), no sample repository for the collection of biological fluids or tissue is planned. However, participants are asked for permission to use stored blood samples or other biological samples that have been left over and stored after an individual diagnostic procedure (e.g. use of liver biopsy samples to perform an additional staining technology).
Data analysis
The full data set can be used in an analysis of a specific project. However, on-going standard analysis of data will include a full description of the population in order to optimise the medical management at the participating centres. The following list of routine analyses is planned:
· The changing demographics of PWUD attending opioid substitution programmes in Switzerland
· Changing trends in the use of illicit and recreational drugs
· The increasing burden of various somatic and psychiatric diseases (prevalence, incidence, hospitalisations) in PWUD in Switzerland
· The prevalence, incidence as well as need of and access to treatment of various diseases (e.g. hepatitis C) in PWUD
- to influence public health decisions on the allocation of resources, and
- to evaluate the efficacy and cost-effectiveness of prevention measures (e.g. the reduction of HCV community viral load by increased HCV treatment up-take)
· The barriers to treatment and outcome for various diseases (e.g. hepatitis C) with the aim to develop strategies to facilitate treatment access and optimise treatment for PWUD
· The quality of care (national and international benchmarking)
Acknowledgement
We thank Dr. Mathieu Rougemont for his input and work allowing the start of the cohort at the HUG, Geneva.
Ethical approval
The SAMMSU Cohort Protocol has been approved by the following ethics commissions:
St. Gallen (Leading ethics commission, Principal Investigator: Andrea Bregenzer)
Bern
Geneva
North West and Central Switzerland
Ticino
Vaud
Zurich