Are Multimorbidity and Related Factors Associated With Non-response Bias in Patients With Spinal Pain? - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Multimorbidity Treatment Burden Questionnaire (MTBQ).
研究概览
简要总结
The study aims to explore if non-response bias exists among individuals with chronic back pain, focusing on the impact of chronic disease count, treatment burden from multimorbidity, and health-related quality of life. Data is gathered from patients at Aalborg University Hospital's Rheumatology Department via electronic means and medical records. The analysis comprises two-wave assessments, investigating disparities among patients responding to study invitations based on response patterns: first, second, or third invitation responses. Utilizing baseline data, a one-way ANOVA is employed to detect potential between-group variations in the mentioned factors. Subsequently, a repeated measures ANOVA is conducted to evaluate differences among groups over time. Additionally, statistical analyses are conducted to scrutinize variances in age and gender distribution between respondents and non-respondents to the questionnaire invitations at baseline.
详细描述
Backgrpund:
The interaction between back pain, multimorbidity, and treatment burden can negatively affect patients' participation in treatment pathways and thus their prognosis. However, this has not been sufficiently investigated. A challenge in data collection through, for example, questionnaires is to ensure representative responses from a patient group with expected high treatment burden and lower health literacy. Selective participation can lead to non-response bias and affect conclusions about the impact of multimorbidity on prognoses for individuals with back pain. Therefore, the aim to investigate whether the number of chronic diseases, the treatment burden associated with multimorbidity, and health-related quality of life contribute to non-response bias in this specific population group.
Objectives:
The objectives of this study will be threefold:
- To examine baseline differences in number of chronic diseases, treatment burden and health-related quality of life among individuals categorized into groups based on their response patterns at baseline.
- To examine the differences between the aforementioned groups over time (baseline, 3 months, and 6 months).
- Assess differences in age and sex distribution between responders and non-responders referred for assessment of back pain to questionnaires evaluating their condition.
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
- •18 years old or above
- •Diagnosed with neck or back pain and the diagnosis was established by or confirmed by a rheumatologist (clinical expert opinion)
- •Speak, read and understand Danish
排除标准
- •Withdraw consent
结局指标
主要结局
Multimorbidity Treatment Burden Questionnaire (MTBQ).
时间窗: This PROM is collected at baseline, 3- and 6 month follow up
The MTBQ is a 10-item self-report measure designed to assess the burden experienced by individuals with multiple health conditions. The ten items cover various aspects of treatment burden, such as managing one's own health, including self-monitoring and lifestyle changes, dealing with medication-related challenges (e.g., adherence and obtaining prescriptions), coordinating healthcare appointments, and managing dependency on others. Each item was scored on a scale ranging from 0 to 100. A higher total score on the questionnaire indicates a higher burden. The MTBQ has been shown to possess good content validity, construct validity, reliability, and responsiveness and has a valid version in Danish.
次要结局
- Health-related quality of life (EQ-5D-5L)(This PROM is collected at baseline, 3- and 6 months follow up)
研究者
Jacob Christiansen Gandløse
Principal investigator
Aalborg University Hospital