Psychiatric Comorbidity in Back Pain Disorders - Risk, Treatment and Pharmaco-epidemiological Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500,000
- 主要终点
- Difference in odds of treatment of back pain between patients with psychiatric comorbidity and patients without psychiatric comorbidity (Study 2)
研究概览
简要总结
Introduction: Studies focusing on back pain do not compare different types of back pain diagnosis in relation to a specific psychiatric comorbidity, nor if the presence of psychiatric comorbidity affects treatment. There are limited knowledge on pharmacological treatment of back pain disorders,and especially if the presence of psychiatric comorbidity is an ad-on to the dosage of medication prescribed. Investigating the use of opioids and other pain medication in back patients and the potential effect of concomitant psychiatric comorbidity as well as taking psychiatric medication under consideration is therefore relevant.
Aim: This aim of this PhD thesis is:
- to estimate the prevalence of psychiatric comorbidity in patients with back pain disorders (BPD) compared to patients with no back pain. 2) Investigate if psychiatric comorbidity affects the type of treatment given. 3) Examine if the presence of psychiatric comorbidity affects the levels of pharmacological treatment given with a focus on both pain medication, such as opioids, as well as treatment with psychotropic medication.
Methods:The association between back pain disorders and psychiatric comorbidity will be investigated using population-based registry data. The population will be defined as adult patients (+18) with a relevant back pain disorder using The National Danish Patient Registry.
The following registries will be also utilized: A subdivision of the DNPR, the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database, The Danish National Health Service Register and the DREAM database. By using the Danish Civil Registry and the unique personal identification number assigned to all Danish citizens at birth, data across registries can be linked on an individual level.
Ethics:The Region of Southern Denmark is the data controller for this project, and it is included in their records of personal data processing activities (file no. (18/3337).). Additional approvals or consents were not needed for this project based exclusively on national registries according to Danish law. The data processing was conducted according to EU and Danish legislation on processing of sensitive personal information and, as complies with internal regulations from the Region of Southern Denmark.
详细描述
Aim of the thesis
The aim of this PhD thesis is to use population-based registry data to:
- Estimate the occurrence of psychiatric comorbidity in a Danish nationwide population of patients with back pain disorders (BPD) diagnosed in 2010-2014; 2) Investigate whether presence of psychiatric comorbidity affects utilization of pharmacological, surgical and other types of treatment for patients with back BPD; 3) Investigate whether presence of psychiatric comorbidity affects utilization and dosages of pharmacological treatment for patients with BPD.
Clinical contributions of this PhD: This PhD study will contribute with new knowledge on the association between different types of back pain disorders (BPD) and psychiatric comorbidity. As BPD affects a large part of the population, this is a very important area of research from a public health and clinical perspective. Access to nationwide registries facilitates a comprehensive and population-based dataset, ensuring the ideal circumstances for investigating the association between BPD and potential psychiatric comorbidity. Furthermore, the results can be used to increase clinical awareness of vulnerable patients in the intersection between rheumatology and psychiatry and subsequently improve prevention and clinical management for a complex and resource-demanding patient population.
Materials and methods
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-10 diagnosis of a relevant back pain disorder (DM*)
- •Registered in the Danish National Patient Registry in the time period 2010-2014.
排除标准
- 未提供
结局指标
主要结局
Difference in odds of treatment of back pain between patients with psychiatric comorbidity and patients without psychiatric comorbidity (Study 2)
时间窗: Calculated over a five year period
The primary outcome is the difference in odds between surgical, pharmacological, and usage of supplementary treatment (defined as number of visits at; chiropractor, physiotherapist, psychologist) in patients with back pain and psychiatric comorbidity and back patients without psychiatric comorbidity.The information will be retrieved from the following nationwide Danish registries: The Danish health registries, including The Danish National Patient Registry (DNPR), a subdivision of the DNPR, the National Patient Registry - Psychiatry (NPD-Psych), The Danish National Prescription Database and The Danish National Health Service Register, contains complete data on hospital contacts, prescription drug use and services provided by health contractors. By using the Danish Civil Registry and the unique personal identification number assigned to all Danish citizens at birth, data across registries can be linked on an individual level.
Occurrence of psychiatric comorbidity (%) retrieved from Danish nationwide registries (Study 1)
时间窗: Calculated over a five year period
The primary outcome is the occurrence of psychiatric comorbidity in patients with back pain compared to the prevalence in a matched population 1:5 without back pain diagnosis. The matched cohort are randomly selected and matched on sex and age. Psychiatric comorbidity will be defined as the presence of any of the following diagnosis, according to ICD-10 classification obtained from the National Patient Registry - Psychiatry (NPD-Psych), covering all inpatient and outpatient psychiatric services in Denmark in the time period 1th January 2007 to 31th December 2017: F00-99\*.
Difference in pharmacological treatment in DDD's (Daily defined dosages) of patients with back pain with and without psychiatric comorbidity, retrieved from the Danish nationwide registries (Study 3).
时间窗: Calculated over a five year period
Primary outcome is pharmacological treatment in Daily Defined Dosages (DDD)defined as high (above the 50th percentile and low (below the 50th percentile) of pain medication prescribed to patients with back pain. Information on DDD's will be retrieved from the Danish Prescription database. Pharmacological treatment of BPD will be defined as any treatment with the following drugs: NSAID (ATC: N01A\*), Acetominophen (ATC: N02BE01), Opioids (N02A\*).
次要结局
- Difference in odds of treatment of back pain between patients with specific and unspecific back pain with presence of psychiatric comorbidity (Study 2)(Calculated over a five year period)
- Difference between patients with back pain and psychiatric comorbidity with high vs. low dosage of pain medication calculated in DDDs (daily defined dosage) in treatment with psychiatric medication retrieved from Danish nationwide registries (Study 3)(Calculated over a five year period)
- Occurrence of psychiatric comorbidity (%) retrieved from Danish nationwide registries (Study 1)(Prevalence calculated over the duration of five years)