Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333847
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-21
Brief Title:
Are Multimorbidity and Related Factors Associated With Non-response Bias in Patients With Spinal Pain
Sponsor:
Jacob Christiansen Gandløse
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Are Multimorbidity and Related Factors Associated With Non-response Bias in Patients With Spinal Pain - A Prospective Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Hospitals 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
Detailed Description:
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
1 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
2 To examine the differences between the aforementioned groups over time baseline 3 months and 6 months
3 Assess differences in age and sex distribution between responders and non-responders referred for assessment of back pain to questionnaires evaluating their condition
Through these methods the aim to uncover any potential non-response bias which can provide insights for future research This examination will aid in determining the most effective approach to investigating the influence of multimorbidity on individuals with back pain
Methods
In this observational cohort study data is gathered from patients referred to the Rheumatology Department of Aalborg University Hospital for back pain Conducted from June 2023 to April 2024 the study recruits participants through electronic links and reminders via E-Boks Information is sourced from three channels the departments booking plan providing details on age and gender of non-responding patients medical records and electronic questionnaires Patient-reported outcomes are collected at baseline and during 3- and 6-month follow-ups using REDCap
Patient characteristics include
From electronic questionnaire smoking habits alcohol consumption Body mass index highest achieved education marital status and work status
From medical records sex chronic health conditions and use of pain medication
Please refer to the section outcome measures for details regarding the PROMS
In this study multimorbidity is defined as the simultaneous presence of at least two chronic conditions within an individual The percentage of patients meeting these criteria will be reported along with a table detailing the frequency of each specific disease
The patients referred to the department during the time period will be divided into a total of 5 groups
Group 1 Patients who responded to the first invitation to participate Group 2 Patients who responded to the second invitation to participate Group 3 Patients who responded to the third invitation to participate
In addition two groups are formed
Group 4 Patients who dit not respond to any inviations to participate Group 5 an amalgamation of people from the three groups above
Statistical analyses
Aim 1 To assess baseline differences between groups 12 and 3 one-way ANOVA with number of diseases as primary outcome and MTBQ and EQ-5D-5L as secondary outcomes will be employed
Aim 2 To assess between-group differences at baseline 3- and 6 months follow up a repeated measurement analysis RM ANOVA will be employed with number of diseases as primary outcome and MTBQ and EQ-5D-5L as secondary outcomes
Additionally patient characteristics across the three groups will be presented in a table with appropriate statistical tests used to measure baseline differences eg chi-square test for categorical variables Results of the repeated measures ANOVA will be visually depicted using bar charts accompanied by error bars
Imputation will be carried out for missing data if considered appropriate
Additionally chi-square test will be employed to assess any differences between group 4 and 5 in terms of gender distrubution Unpaired t-test will be employed to assess any difference between group 4 and 5 in terms of age
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
1 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
2 To examine the differences between the aforementioned groups over time baseline 3 months and 6 months
3 Assess differences in age and sex distribution between responders and non-responders referred for assessment of back pain to questionnaires evaluating their condition
Through these methods the aim to uncover any potential non-response bias which can provide insights for future research This examination will aid in determining the most effective approach to investigating the influence of multimorbidity on individuals with back pain
Methods
In this observational cohort study data is gathered from patients referred to the Rheumatology Department of Aalborg University Hospital for back pain Conducted from June 2023 to April 2024 the study recruits participants through electronic links and reminders via E-Boks Information is sourced from three channels the departments booking plan providing details on age and gender of non-responding patients medical records and electronic questionnaires Patient-reported outcomes are collected at baseline and during 3- and 6-month follow-ups using REDCap
Patient characteristics include
From electronic questionnaire smoking habits alcohol consumption Body mass index highest achieved education marital status and work status
From medical records sex chronic health conditions and use of pain medication
Please refer to the section outcome measures for details regarding the PROMS
In this study multimorbidity is defined as the simultaneous presence of at least two chronic conditions within an individual The percentage of patients meeting these criteria will be reported along with a table detailing the frequency of each specific disease
The patients referred to the department during the time period will be divided into a total of 5 groups
Group 1 Patients who responded to the first invitation to participate Group 2 Patients who responded to the second invitation to participate Group 3 Patients who responded to the third invitation to participate
In addition two groups are formed
Group 4 Patients who dit not respond to any inviations to participate Group 5 an amalgamation of people from the three groups above
Statistical analyses
Aim 1 To assess baseline differences between groups 12 and 3 one-way ANOVA with number of diseases as primary outcome and MTBQ and EQ-5D-5L as secondary outcomes will be employed
Aim 2 To assess between-group differences at baseline 3- and 6 months follow up a repeated measurement analysis RM ANOVA will be employed with number of diseases as primary outcome and MTBQ and EQ-5D-5L as secondary outcomes
Additionally patient characteristics across the three groups will be presented in a table with appropriate statistical tests used to measure baseline differences eg chi-square test for categorical variables Results of the repeated measures ANOVA will be visually depicted using bar charts accompanied by error bars
Imputation will be carried out for missing data if considered appropriate
Additionally chi-square test will be employed to assess any differences between group 4 and 5 in terms of gender distrubution Unpaired t-test will be employed to assess any difference between group 4 and 5 in terms of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None