Social Participation in Patients With Multiple Sclerosis
Social Participation in Patients With Multiple Sclerosis
Researchers recruited consecutively a sample of patients with MS who have monthly infusion of natalizumab, at the Neurology Department, St Vincent de Paul Hospital, Lille, France. Inclusion criteria were a diagnosis of MS, an on-going treatment with natalizumab and to be at least 18 years old. Exclusion criteria were inability to read/understand French, or unwillingness to participate. Table 1 provides a summary of participants' demographic and medical information. This preliminary study was a part of a larger study that was approved by the local ethic committee named "Comité de Protection des Personnes Nord Ouest IV" (number SC 11/02). A written informed consent was obtained from patients who agreed to participate. Due to non-randomised inclusion of participants in a unique centre and to limited time available to this first study, the investigators chose to include only a representative sample of patients who were treated with the same molecule, here natalizumab.
Social participation The Impact on Participation and Autonomy Questionnaire (IPA) assess the perceived personal impact of chronic disability on participation and autonomy. Effectively, World Health Organisation's International Classification of Functioning, Disability and Health (ICF) was developed in 2001, inspired by theorical researches in the forty last years, such as Amartya Sen's theory who define notions of functioning and capabilities. In this context, the conceptual framework of social participation has been defined as "the involvement of an individual in life situations in relation to health conditions, body function and structures, activities and contextual factors". The IPA was developed and validated by Cardol and colleagues in the Netherlands. The IPA was translated into English and validated for using by patients which have disabilities due to MS, rheumatoid arthritis and spinal cord injury. A French version was equally validated by Canadian researchers for elderly people. The IPA contains 32 items which load onto five domains termed: autonomy indoors; family role; autonomy outdoors; social life and relationships; work and education. Scores for each domain range from 0 ("very good") to 4 ("very poor"); lower scores indicate better social participation and autonomy. In the validation study of IPA questionnaire from UK, the control group participants with mild or no disability had median scores near from 0 (0 to 0.2) in all five domains from IPA. Patients with MS experienced median scores between 0.67 to 2.2.
Generic QOL questionnaire and utility The EQ5D-VAS is a generic preference-based measure of health-related QOL that consists of two parts. The first part includes five domains (each divided in 3 levels: no problem, some problems and extreme problems), which are termed: mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression. It permits to define 243 health states, which are valued in term of utility using a value set recently published in French population, where 0 is equivalent to death and 1 is a good health. The second part is a Visual Analogue Scale to measure self-perceived health with values from 0 to 100 (data not shown).
MS specific QOL questionnaire SEP-59 questionnaire is the validated French version of MSQOL-54, an international-used MS specific QOL questionnaire, which combines the MOS SF36 together with MS specific items. It contains 59 items divided in 15 domains named: physical function, role limitation – physical, role limitation – emotional, social function, pain, energy/fatigue, emotional well-being, health perception, health distress, cognitive function, sexual function, sexual satisfaction, overall QOL, sleep and social support. Scores for each domain range from 0 to 100; higher scores indicate better health status, except for the pain subscale. The MSQOL-54 questionnaire, scored according to the User' Manual, permits to produce two aggregated scores which are a physical health QOL score (MSQOL-P) and a mental health QOL score (MSQOL-M).
Medico-economic, demographic and clinical data The investigators completed a detailed questionnaire for each patient. This included questions on socio demographic characteristics, health status (type of MS, disease duration, relapse rate in the last year), clinical examination with EDSS measurement, concomitant health conditions, questions to determine direct costs (medical drugs, out-patient visits, hospitalizations related to MS, paraclinical tests, laboratory tests, transportation - ambulances, multidisciplinary care, mobility aids and home furnishings, professional care services at home and informal care, …) and questions to determine indirect direct costs (employment absenteeism, temporary or permanent reduction of working time or income, early retirement due to disability).
The data were collected during face-to-face interviews of 45 to 60 minutes. First the patient responded alone to three self-administered questionnaires. Then the investigator completed a medico-economic questionnaire with the patient. Depending on the type of information, the patient was asked about the period from the 3 to 12 last months.
The data were analysed using SPSS version 18.0. Descriptive statistics are reported for the whole cohort and split into 3 groups according to EDSS level. Definitions of the 3 groups were decided before analysis. Ability to walk without limits defined the first group (EDSS < 4). Absence (EDSS between 4 and 5.5) or requirement of assistance (EDSS ≥ 6) to walk a limited distance defined the other two groups. Comparisons between groups were analysed using the Conover free distribution (one-factor ANOVA on ranks). When latter test showed significant group differences, post-hoc tests were then performed. The level of significance of comparisons was set at p = 0.05.
Concerning economic burden analysis, a societal perspective was adopted, in which all costs were considered without regard to the entity that pays. Costs were calculated as mean annual costs per patient. For direct costs, monetary values per unit were obtained from official sources in French administration: hospital activity tariffs (T2A), national health insurance tariffs and national price list for drugs (http://www.ameli.fr). Indirect costs for lost productivity were evaluated by a method named "human capital approach", where the production of a person is valued at the market price (in this case, the sex-specific average salary including employers' costs) using national labour statistics (http://www.insee.fr). For short-term sick leave, labour costs were adjusted to patients' working hours, whereas for long-term sick leave and early retirement due to MS, the national average annual working time by sex was used. Informal care was estimated by the replacement method, where the care would be provided by a professional (driver, housekeeper, babysitter…) rather than a family member.
Correlations were explored with Spearman coefficient(r) and were considered significant with an alpha level of 0.01.
Post-hoc analysis on employment status included comparisons with Wilcoxon-Mann–Whitney test between participants who have a job and those who had not.
The report provides Class IV evidence and is a single observational study without controls.
Methods
Study Participants
Researchers recruited consecutively a sample of patients with MS who have monthly infusion of natalizumab, at the Neurology Department, St Vincent de Paul Hospital, Lille, France. Inclusion criteria were a diagnosis of MS, an on-going treatment with natalizumab and to be at least 18 years old. Exclusion criteria were inability to read/understand French, or unwillingness to participate. Table 1 provides a summary of participants' demographic and medical information. This preliminary study was a part of a larger study that was approved by the local ethic committee named "Comité de Protection des Personnes Nord Ouest IV" (number SC 11/02). A written informed consent was obtained from patients who agreed to participate. Due to non-randomised inclusion of participants in a unique centre and to limited time available to this first study, the investigators chose to include only a representative sample of patients who were treated with the same molecule, here natalizumab.
Instruments
Social participation The Impact on Participation and Autonomy Questionnaire (IPA) assess the perceived personal impact of chronic disability on participation and autonomy. Effectively, World Health Organisation's International Classification of Functioning, Disability and Health (ICF) was developed in 2001, inspired by theorical researches in the forty last years, such as Amartya Sen's theory who define notions of functioning and capabilities. In this context, the conceptual framework of social participation has been defined as "the involvement of an individual in life situations in relation to health conditions, body function and structures, activities and contextual factors". The IPA was developed and validated by Cardol and colleagues in the Netherlands. The IPA was translated into English and validated for using by patients which have disabilities due to MS, rheumatoid arthritis and spinal cord injury. A French version was equally validated by Canadian researchers for elderly people. The IPA contains 32 items which load onto five domains termed: autonomy indoors; family role; autonomy outdoors; social life and relationships; work and education. Scores for each domain range from 0 ("very good") to 4 ("very poor"); lower scores indicate better social participation and autonomy. In the validation study of IPA questionnaire from UK, the control group participants with mild or no disability had median scores near from 0 (0 to 0.2) in all five domains from IPA. Patients with MS experienced median scores between 0.67 to 2.2.
Quality of Life
Generic QOL questionnaire and utility The EQ5D-VAS is a generic preference-based measure of health-related QOL that consists of two parts. The first part includes five domains (each divided in 3 levels: no problem, some problems and extreme problems), which are termed: mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression. It permits to define 243 health states, which are valued in term of utility using a value set recently published in French population, where 0 is equivalent to death and 1 is a good health. The second part is a Visual Analogue Scale to measure self-perceived health with values from 0 to 100 (data not shown).
MS specific QOL questionnaire SEP-59 questionnaire is the validated French version of MSQOL-54, an international-used MS specific QOL questionnaire, which combines the MOS SF36 together with MS specific items. It contains 59 items divided in 15 domains named: physical function, role limitation – physical, role limitation – emotional, social function, pain, energy/fatigue, emotional well-being, health perception, health distress, cognitive function, sexual function, sexual satisfaction, overall QOL, sleep and social support. Scores for each domain range from 0 to 100; higher scores indicate better health status, except for the pain subscale. The MSQOL-54 questionnaire, scored according to the User' Manual, permits to produce two aggregated scores which are a physical health QOL score (MSQOL-P) and a mental health QOL score (MSQOL-M).
Medico-economic, demographic and clinical data The investigators completed a detailed questionnaire for each patient. This included questions on socio demographic characteristics, health status (type of MS, disease duration, relapse rate in the last year), clinical examination with EDSS measurement, concomitant health conditions, questions to determine direct costs (medical drugs, out-patient visits, hospitalizations related to MS, paraclinical tests, laboratory tests, transportation - ambulances, multidisciplinary care, mobility aids and home furnishings, professional care services at home and informal care, …) and questions to determine indirect direct costs (employment absenteeism, temporary or permanent reduction of working time or income, early retirement due to disability).
Procedure
The data were collected during face-to-face interviews of 45 to 60 minutes. First the patient responded alone to three self-administered questionnaires. Then the investigator completed a medico-economic questionnaire with the patient. Depending on the type of information, the patient was asked about the period from the 3 to 12 last months.
Data Analysis
The data were analysed using SPSS version 18.0. Descriptive statistics are reported for the whole cohort and split into 3 groups according to EDSS level. Definitions of the 3 groups were decided before analysis. Ability to walk without limits defined the first group (EDSS < 4). Absence (EDSS between 4 and 5.5) or requirement of assistance (EDSS ≥ 6) to walk a limited distance defined the other two groups. Comparisons between groups were analysed using the Conover free distribution (one-factor ANOVA on ranks). When latter test showed significant group differences, post-hoc tests were then performed. The level of significance of comparisons was set at p = 0.05.
Concerning economic burden analysis, a societal perspective was adopted, in which all costs were considered without regard to the entity that pays. Costs were calculated as mean annual costs per patient. For direct costs, monetary values per unit were obtained from official sources in French administration: hospital activity tariffs (T2A), national health insurance tariffs and national price list for drugs (http://www.ameli.fr). Indirect costs for lost productivity were evaluated by a method named "human capital approach", where the production of a person is valued at the market price (in this case, the sex-specific average salary including employers' costs) using national labour statistics (http://www.insee.fr). For short-term sick leave, labour costs were adjusted to patients' working hours, whereas for long-term sick leave and early retirement due to MS, the national average annual working time by sex was used. Informal care was estimated by the replacement method, where the care would be provided by a professional (driver, housekeeper, babysitter…) rather than a family member.
Correlations were explored with Spearman coefficient(r) and were considered significant with an alpha level of 0.01.
Post-hoc analysis on employment status included comparisons with Wilcoxon-Mann–Whitney test between participants who have a job and those who had not.
Level of Evidence
The report provides Class IV evidence and is a single observational study without controls.
Source...