Pain Clinical Trial
Official title:
Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany
Verified date | September 2019 |
Source | LinkCare GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Among patients receiving opioids for noncancer pain, recent research in North America showed a strong association between doses and opioid-related mortality, especially at dosages exceeding thresholds recommended in recent guidelines. However, the focus on over-dosage may underestimate overall opioid-related mortality and data on death associated with opioid use in a population-based cohort of chronic noncancer pain patients in Europe is scarce. Especially comparative studies studying the safety of long-term opioid therapy in a real-world setting relative to non-opioid medication for chronic noncancer pain are needed in a European context.
Status | Completed |
Enrollment | 3232 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients are only included if they have been diagnosed in at least three quarters in the study period with one of the following diagnoses: R51, R52*, M00*-M99*, G43*-G44*, G50.0 or G50.1, F45.4*, G62*, or E10.4*-E14.4 plus G63.3. At least one diagnoses must be between 1 January 2012 and index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be used to include the patients. Exclusion Criteria: - Patients with present opioid and non-opioid pain medication prescriptions in 2012 are excluded from analysis (therapy-naïve patients only). - Cancer patients will be excluded if the cancer diagnosis is accompanied by at least one of the following treatments in the same quarter: radiation therapy or chemotherapy all defined by the OPS codes in. Diagnoses will be assessed via ICD-10 diagnoses during the inclusion period from 1 January 2012 until index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be taken into account. - Palliative care, coded by ICD-10 code Z51.5 or OPS code 8-982*, 8-98e*, 8-98h* before index date is excluded - Opioid substitution treatment with ICD-10 code Z51.83 in the study period is excluded. |
Country | Name | City | State |
---|---|---|---|
Germany | LinkCare GmbH | Stuttgart |
Lead Sponsor | Collaborator |
---|---|
LinkCare GmbH | Grünenthal GmbH, Klinikum Saarbrücken, Ruhr University of Bochum, Technische Universität München |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | Primary endpoint is death by any course in the study follow-up. Death will be assessed during the follow-up period by number of patients who deceased during follow-up period (2013 - 2017) via the date of death in German claims data base. | 2013 - 2017 | |
Secondary | Hospitalization due to any course | Hospitalization will be assessed via the number of hospitalisations (calculated by counting the number of discharge dates (KH_Fall. Entlassungsdatum) in the year of interest, hospitalization rate. The rate of hospitalization will be estimated as the number of patients with at least one hospitalization during the follow-up period divided by person-time of follow-up, censoring at time of death, last known record for the patient in the database, or 31st December 2017 (end of latest data cut), whichever is earlier. | 2013 - 2017 | |
Secondary | Number of ICU-stays | Intensive care unit (ICU-stay) stay is defined as patient's stay based on specialty of departement in hospital (KH_OPS.Fachabteilung = 3600). | 2013 - 2017 | |
Secondary | Hospitalization with to misuse or addiction | The hospitalization with misuse or addiction will be analysed, if principal (main) diagnosis at discharge date between January 1st 2013 and December 31st 2017 contains at least one ICD-10 diagnosis of misuse/addiction: F10* or F11* or F13* or F19* or T40* | 2013 - 2017 | |
Secondary | Number of coding of procedures in hospitals | Coding of procedures in hospitals that indicate number of patients that were hospitalized with severe diseases such as cardiovascular diseases will be assessed via OPS-Codes provided in the protocol | 2013 - 2017 | |
Secondary | Number of patients with a ca misuse or addiction diagnosis in the outpatient sector | The number of patients with a least one coding of ICD 10 codes of a misuse or addiction diagnosis in the outpatient sector will be assessed via number of codings of misuse/addiction (ICD Codes = F10* or F11* or F13* or F19* or T40*) in outpatient sector by general practitioner or a specialist (e.g. psychiatrist), as ensured diagnosis (Diagnosesicherheit='G'). | 2013 - 2017 | |
Secondary | Number of sick leave days | Sick leave will be assessed as an absolute number number of days being off work of patients in 2013-2017 . | 2013 - 2017 | |
Secondary | Number of hospital deaths | Hospital deaths will be assessed via reason of discharge = death (Entlassgrund = Tod) | 2013 - 2017 | |
Secondary | Number of main- and secondary discharge diagnoses | Main- and secondary discharge diagnoses from hospital deaths will be assessed as the TOP 20 diagnoses of patients who deceased during a hospital stay | 2013 - 2017 |
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