Cross-cultural Validation of the French Version of the Lymphedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphedema (Lymph-ICF-LL) and Responsiveness of the Dutch Version of the Lymph-ICF-LL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 3
- 主要终点
- Reliability of the French Lymph-ICF-LL questionnaire (test-retest)
研究概览
简要总结
The goal of this observational study is to cross-validate the Lymphedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphedema (Lymph-ICF-LL) in French and to investigate the responsiveness of the original Dutch Lymph-ICF-LL questionnaire in patients with lower limb lymphedema. The main questions it aims to answer are:
- The reliability of the French Lymph-ICF-LL
- The validity of the French Lymph-ICF-LL
- The responsiveness of the original Dutch Lymph-ICF-LL
Participants are asked to complete questionnaires (Lymph-ICF-LL, Short Form-36, Global Perceived Effect Scale, questionnaire about the face and content validity) at two time points.
详细描述
- For reliability of the French Lymph-ICF-LL questionnaire:
Native French speaking patients with stable lower limb lymphedema (LLL) (= in the maintenance phase of the treatment and no intensive multicomponent bandaging is required) are asked to complete the Lymph-ICF-LL questionnaire twice with an interval of 1-2 days in between.
For the test-retest reliability following outcomes are calculated: Intraclass Correlation Coefficient(2,1), standard error of measurement and the smallest real difference.
For internal consistency the Cronbach's alpha is calculated for the first completion of the questionnaire. 2. For the validity of the French Lymph-ICF-LL questionnaire, the construct validity, face and content validity are determined.
2.1: For construct validity (=convergent and divergent validity), patients with stable lower limb lymphedema are asked to additionally complete the 36-item Short-Form Health survey (=health-related quality of life questionnaire) together with the first completion of the Lymph-ICF-LL questionnaire. For convergent validity, hypotheses are formulated about significant correlations between domains of the 36-item Short-Form Health survey (=SF-36) and domains of the Lymph-ICF-LL questionnaire which are expected to evaluate a similar construct: 'Physical functioning' of SF-36 and 'general tasks/household', 'mobility', 'life domains/social life' of the Lymph-ICF-LL; 'Role limitations due to physical health problems' of SF-36 and 'General tasks/household' of Lymph-ICF-LL; 'Bodily pain' of SF-36 and 'Physical function' of Lymph-ICF-LL; 'Social functioning' of SF-36 and 'Life domains/ social life' of Lymph-ICF-LL; 'Role limitations due to personal or emotional problems' of SF-36 and 'Mental function' of Lymph-ICF-LL; 'Mental health' of SF-36 and 'Mental function' of Lymph-ICF-LL. For divergent validity, hypotheses are formulated about weak or non-significant correlations between domains of the SF-36 and Lymph-ICF-LL: 'Physical functioning' of SF-36 and 'Mental function' of Lymph-ICF-LL; 'Role limitations due to personal or emotional problems' of SF-36 and 'Physical function' Lymph-ICF-LL; 'Mental health' of SF-36 and 'General tasks/household', 'Mobility', 'Life domains/social life' of Lymph-ICF-LL. These hypotheses were also used in previous published research of the validation of the original Dutch Lymph-ICF-LL questionnaire. Spearman rank correlation coefficients were calculated for this purpose.A correlation coefficient below .25 represent no to a little relationship, a value between .25 and .50 indicates a low to fair relationship, a value between .50 and .75 is interpreted as a moderate to good relationship and a value above or equal to .75 as a strong relationship.
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
- •Primary or secondary lymphedema at the lower limb(s), i.e. a difference of ≥5% in volume between the two sides or a lymphoscintigraphy which shows at least 2 minor criteria or 1 major criterion or presence of indocyanine green (ICG) dermal backflow
- •Unilateral/bilateral lymphedema
- •Lymphedema stage 1, 2a, 2b or 3
- •Lymphedema is present >3 months
- •Chemotherapy and radiotherapy was finished >3 months ago
- •Native French-speaking or Dutch-speaking for study about the French or Dutch Lymph-ICF-LL, respectively
- •During the study patients are in the maintenance phase and not in the intensive phase (for the reliability/validity/responsiveness); patients receive intensive treatment in the hospital (for the responsiveness)
- •Given informed consent to participate
- •>18 years old
排除标准
- •Not able to read or fully understand the French or Dutch language for study about the French or Dutch Lymph-ICF-LL, respectively
- •For the reliability and validity and for part of the responsiveness: first treatment for lymphedema < 6 months ago and an intensive phase is planned or needed according to a specialized caregiver in treating lymphedema
- •<18 years old
- •Pregnant or breastfeeding women
结局指标
主要结局
Reliability of the French Lymph-ICF-LL questionnaire (test-retest)
时间窗: Baseline and 1-2 days later
Following aspects were assessed to investigate the reliability of the French Lymph-ICF-LL: Test-retest relative reliability Patients completed the Lymph-ICF-LL two times with an interval of 1-2 days. The total score and subdomain scores are calculated: (sum of scores divided by the number of completed questions)\*10. This results in a score between 0 and 100 in which 0 reflects a better lymphedema-specific quality of life and 100 a worse lymphedema-specific quality of life. The intraclass correlation coefficient (2,1) (ICC) is calculated between the first and second completion. An ICC above .90 is interpreted as excellent relative reliability, an ICC between .75 and .90 as good, an ICC between .50 and .75 as moderate and an ICC below .50 as poor relative reliability.
Reliability of the French Lymph-ICF-LL questionnaire (standard error of measurement)
时间窗: Baseline and 1-2 days later
Standard error of measurement (SEM) reflects absolute reliability between the total and subdomain scores of the Lymph-ICF-LL questionnaires at baseline and 1-2 days later. The SEM is calculated with the square root of mean square error determined by ANOVA.
Reliability of the French Lymph-ICF-LL questionnaire (smallest real difference)
时间窗: Baseline and 1-2 days later
Smallest Real Difference (SRD) between the total and subdomain scores of the two Lymph-ICF-LL questionnaire completions at baseline and 1-2 days later was calculated by 1.96 multiplied by SEM and square root of 2.
Reliability of the French Lymph-ICF-LL questionnaire
时间窗: Baseline (first completion of the Lymph-ICF-LL questionnaire)
Internal consistency with Cronbach's alpha of the different domains and total score. A Cronbach's alpha between .70 and .90 is considered as a good internal consistency
次要结局
- Face and content/floor & ceiling effects of the French Lymph-ICF-LL(Baseline)
- Construct validity of the Lymph-ICF-LL(Baseline)
- Internal responsiveness of the Lymph-ICF-LL(At start of the intensive phase and 1 month after the end of the intensive phase (patients receiving intensive treatment) or at baseline and 2 months later (patients with stable lower limb lymphedema))
- External responsiveness(Start of the intensive phase and 1 month after the end of the intensive phase (patients receiving intensive treatment) or baseline an 2 months later (patients with stable lower limb lymphedema in the stable phase))