Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey
BackgroundMedical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
JMIR Publications
2023-03-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2023/1/e38814 |
| _version_ | 1797734282713628672 |
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| author | Jan Moritz Fischer Farid-Ihab Kandil Matthias Karst Laura Sophie Zager Michael Jeitler Felix Kugler Franziska Fitzner Andreas Michalsen Christian S Kessler |
| author_facet | Jan Moritz Fischer Farid-Ihab Kandil Matthias Karst Laura Sophie Zager Michael Jeitler Felix Kugler Franziska Fitzner Andreas Michalsen Christian S Kessler |
| author_sort | Jan Moritz Fischer |
| collection | DOAJ |
| description |
BackgroundMedical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and their (still) low prevalence in medical contexts. Against this background, patients’ willingness to provide information is limited. Moreover, it is logistically challenging to reach them with a survey. A thorough knowledge of currently ongoing therapies and their effects and side effects, however, is important for a more appropriate and effective use of cannabinoids in the future.
ObjectiveThis study is an exploratory data collection using a representative sample. The main goal is to provide a detailed picture of the current use of medical cannabinoids in Germany. It is intended to identify subgroups that may benefit particularly well or poorly.
MethodsWe are conducting a representative, anonymous, cross-sectional, one-time, web-based survey based on mixed methods in 3 German federal states. Health conditions under cannabinoid therapy and before are documented with validated, symptom-specific questionnaires. This allows an estimation of the effect sizes of these therapies. The selection of parameters and questionnaires was based on the results of independent qualitative interviews in advance. Representative samples of the hard-to-reach study population are obtained by cluster sampling via contracted physicians of the statutory health insurance companies.
ResultsRecruitment was ongoing until the end of June 2022, with 256 enrolled participants. Validated questionnaires on pain, spasticity, anorexia or wasting, multiple sclerosis, nausea or vomiting, depression, and attention deficit hyperactivity disorder (ADHD) were selected. Symptom scores are being assessed for both current conditions under cannabinoid therapy and conditions prior to this therapy (in retrospect). Validated questionnaires are also used for treatment satisfaction and general quality of life. These are supplemented by existing diagnoses, a detailed medication history, any previous experiences with cannabis or illegal substances, experiences with the prescription process, and sociodemographic data. Based on the results of the previous qualitative interviews, questions were added regarding prior experience with relaxation methods and psychotherapy, personal opinions about cannabinoids, pre-existing or symptom-related psychological trauma, and different experiences with different cannabis-based therapies.
ConclusionsThe exploratory mixed methods approach of this project is expected to provide valid and relevant data as a basis for future clinical research. The study design may be representative for a large proportion of outpatients treated with cannabinoids in the German federal states studied. It may have less bias toward social desirability and may provide valuable information in addition to existing studies. Due to the observational and cross-sectional nature of this study, various limitations apply. Causal relations cannot be drawn.
Trial RegistrationGerman Clinical Trials Register DRKS00023344; https://drks.de/search/en/trial/DRKS00023344
International Registered Report Identifier (IRRID)DERR1-10.2196/38814 |
| first_indexed | 2024-03-12T12:40:59Z |
| format | Article |
| id | doaj.art-0959b256a66e4822b93a841957602591 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-03-12T12:40:59Z |
| publishDate | 2023-03-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-0959b256a66e4822b93a8419576025912023-08-28T23:47:30ZengJMIR PublicationsJMIR Research Protocols1929-07482023-03-0112e3881410.2196/38814Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based SurveyJan Moritz Fischerhttps://orcid.org/0000-0002-3495-6495Farid-Ihab Kandilhttps://orcid.org/0000-0003-3071-7902Matthias Karsthttps://orcid.org/0000-0002-3502-0023Laura Sophie Zagerhttps://orcid.org/0000-0001-8092-7217Michael Jeitlerhttps://orcid.org/0000-0003-1717-5897Felix Kuglerhttps://orcid.org/0000-0001-9863-8448Franziska Fitznerhttps://orcid.org/0000-0003-3177-8264Andreas Michalsenhttps://orcid.org/0000-0002-9145-7246Christian S Kesslerhttps://orcid.org/0000-0001-7794-8375 BackgroundMedical cannabinoids are controversial. Their use is comparatively rare, but it is rising. Since 2017, cannabinoids can be prescribed in Germany for a broader range of indications. Patient surveys on these drugs are hampered by the stigmatization of cannabinoids and their (still) low prevalence in medical contexts. Against this background, patients’ willingness to provide information is limited. Moreover, it is logistically challenging to reach them with a survey. A thorough knowledge of currently ongoing therapies and their effects and side effects, however, is important for a more appropriate and effective use of cannabinoids in the future. ObjectiveThis study is an exploratory data collection using a representative sample. The main goal is to provide a detailed picture of the current use of medical cannabinoids in Germany. It is intended to identify subgroups that may benefit particularly well or poorly. MethodsWe are conducting a representative, anonymous, cross-sectional, one-time, web-based survey based on mixed methods in 3 German federal states. Health conditions under cannabinoid therapy and before are documented with validated, symptom-specific questionnaires. This allows an estimation of the effect sizes of these therapies. The selection of parameters and questionnaires was based on the results of independent qualitative interviews in advance. Representative samples of the hard-to-reach study population are obtained by cluster sampling via contracted physicians of the statutory health insurance companies. ResultsRecruitment was ongoing until the end of June 2022, with 256 enrolled participants. Validated questionnaires on pain, spasticity, anorexia or wasting, multiple sclerosis, nausea or vomiting, depression, and attention deficit hyperactivity disorder (ADHD) were selected. Symptom scores are being assessed for both current conditions under cannabinoid therapy and conditions prior to this therapy (in retrospect). Validated questionnaires are also used for treatment satisfaction and general quality of life. These are supplemented by existing diagnoses, a detailed medication history, any previous experiences with cannabis or illegal substances, experiences with the prescription process, and sociodemographic data. Based on the results of the previous qualitative interviews, questions were added regarding prior experience with relaxation methods and psychotherapy, personal opinions about cannabinoids, pre-existing or symptom-related psychological trauma, and different experiences with different cannabis-based therapies. ConclusionsThe exploratory mixed methods approach of this project is expected to provide valid and relevant data as a basis for future clinical research. The study design may be representative for a large proportion of outpatients treated with cannabinoids in the German federal states studied. It may have less bias toward social desirability and may provide valuable information in addition to existing studies. Due to the observational and cross-sectional nature of this study, various limitations apply. Causal relations cannot be drawn. Trial RegistrationGerman Clinical Trials Register DRKS00023344; https://drks.de/search/en/trial/DRKS00023344 International Registered Report Identifier (IRRID)DERR1-10.2196/38814https://www.researchprotocols.org/2023/1/e38814 |
| spellingShingle | Jan Moritz Fischer Farid-Ihab Kandil Matthias Karst Laura Sophie Zager Michael Jeitler Felix Kugler Franziska Fitzner Andreas Michalsen Christian S Kessler Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey JMIR Research Protocols |
| title | Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey |
| title_full | Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey |
| title_fullStr | Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey |
| title_full_unstemmed | Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey |
| title_short | Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and Anonymous Web-Based Survey |
| title_sort | patient experiences with prescription cannabinoids in germany protocol for a mixed methods exploratory and anonymous web based survey |
| url | https://www.researchprotocols.org/2023/1/e38814 |
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