This is a prospective, randomized, non-blinded, multi-center, non-inferiority trial designed to compare effectiveness and side-effects of methotrexate versus prednisone as first-line therapy for pulmonary sarcoidosis.
Sarcoidosis is a multisystem, granulomatous disorder, most commonly affecting the lungs. Symptom burden is high, and quality of life (QoL) and social participation are negatively affected. In patients with pulmonary sarcoidosis, treatment is recommended in case of significant symptoms and/or impaired or deteriorating lung function. Evidence-based treatment recommendations are limited, outdated and largely based on expert opinion. Prednisone is currently the first-choice therapy in pulmonary sarcoidosis and leads to short-term improvement of lung function. Unfortunately, prednisone has major side-effects and is associated with impaired QoL. Methotrexate is presently considered second-line therapy, and appears to have fewer side-effects. The investigators hypothesize that first-line treatment with methotrexate is as effective as prednisone, with fewer side-effects and better QoL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks.
Oral prednisone (start 40 mg daily, to be tapered to 10 mg daily) for 24 weeks.
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Forced Vital Capacity (FVC)
Change in hospital-measured FVC between baseline and 24 weeks
Time frame: 24 weeks after inclusion
Forced Vital Capacity (FVC)
Change in hospital-measured FVC between baseline and 4 weeks.
Time frame: 4 weeks
Forced Vital Capacity (FVC)
Change in hospital-measured FVC between baseline and 16 weeks.
Time frame: 16 weeks
Time to major pulmonary improvement measured by FVC
Time to major pulmonary improvement measured by home-measured FVC, whereby major pulmonary improvement is defined as 80% of the maximum percent predicted FVC reached anywhere during the first 24 weeks of treatment. This will be determined on the home spirometry data.
Time frame: 24 weeks
Change in FVC
The percentage of patients with a 5 and 10% improvement or decline in FVC at 4 weeks.
Time frame: 4 weeks
Change in FVC
The percentage of patients with a 5 and 10% improvement or decline in FVC at 16 weeks.
Time frame: 16 weeks
Change in FVC
The percentage of patients with a absolute 5 and 10% improvement or decline in percent predicted FVC at 24 weeks.
Time frame: 24 weeks
Change in DLCO
The percentage of patients with a 10% or \> 10% improvement or decline in DLCO at 4 weeks.
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Amsterdam, Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Amphia hospital
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
...and 7 more locations
Time frame: 4 weeks
Change in DLCO
The percentage of patients with a 10% or \> 10% improvement or decline in DLCO at 16 weeks.
Time frame: 16 weeks
Change in DLCO
The percentage of patients with a 10% or \> 10% improvement or decline in DLCO at 24 weeks.
Time frame: 24 weeks
Changes in Angiotensin-Converting Enzyme (ACE)
Differences in serum levels of sACE (U/ml) in serum of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in sACE levels during treatment
Differences in serum levels of sACE (U/ml) in serum of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in soluble interleukin-2 receptor (sIL-2R)
Differences in serum levels of sIL-2R (U/ml) in serum of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in sIL-2R levels during treatment
Differences in serum levels of sIL-2R (U/ml) in serum of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in extracellular vesicles during treatment
Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in extracellular vesicles absolute numbers
Differences in absolute numbers of extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in protein expression levels in extracellular vesicles during treatment
Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in protein expression levels in extracellular vesicles
Differences in protein expression in extracellular vesicles in serum of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in T lymphocyte phenotypes during Treatment
Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity). Differences in phenotype of T-cells (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment.
Time frame: 2 years
Between group changes in T lymphocyte phenotypes
Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity). Differences in phenotype of T-cells (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in T lymphocyte absolute cell numbers
Differences in the absolute numbers of T-cells (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in T lymphocyte absolute cell numbers
Differences in the absolute numbers of T-cells (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in the distribution of T lymphocytes during treatment
Differences in the frequencies of T-cells (%) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in the distribution of T lymphocytes
Differences in the frequencies of T-cells (%) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in dendritic cell phenotypes during Treatment
Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity). Differences in phenotype of dendritic cells (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in dendritic cell phenotypes
Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity). Differences in phenotype of dendritic cells (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in dendritic cell absolute cell numbers
Differences in the absolute numbers of dendritic cells (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in dendritic cell absolute cell numbers
Differences in the absolute numbers of dendritic cells (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in the distribution of dendritic cells during treatment
Differences in the frequencies of dendritic cells (%) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in the distribution of dendritic cells
Differences in the frequencies of dendritic cells (%) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in monocyte subset phenotypes during Treatment
Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity). Differences in expression of monocyte specific cell surface markers on monocytes (MFI) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in monocyte subset phenotypes
Flow cytometry analysis will be used to determine how the frequencies and distribution of different cell subtypes change during treatment. Different phenotypes can be identified through expression of a number of cell surface markers, expression is measured in MFI (mean fluorescence intensity). Differences expression of monocyte specific cell surface markers on monocytes (MFI) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in monocyte absolute cell numbers
Differences in the absolute numbers of monocytes (cells/ml) in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in monocyte absolute cell numbers
Differences in the absolute numbers of monocytes (cells/ml) in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Changes in the distribution of monocytes during treatment
Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients before, during and after treatment
Time frame: 2 years
Between group changes in the distribution of monocytes
Differences in the frequencies of monocytes in peripheral blood of sarcoidosis patients on prednisolone versus methotrexate
Time frame: 2 years
Correlation between biomarkers and clinical parameters
The differences in percentage of biomarkers is compared with the differences in change of FVC and DLCOc. Biomarkers are measured in peripheral blood and include: * monocytes, measured by flow cytometry (MFI) * Th-cells, measured by flow cytometry (MFI) * dendritic cells, measured by flow cytometry (MFI) * Proteins, measured by ELISA (ng/ml) * Serum biomarkers (U/l)
Time frame: 2 years
The King's Sarcoidosis Questionnaire (KSQ)
The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete.
Time frame: baseline
The King's Sarcoidosis Questionnaire (KSQ)
The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete.
Time frame: baseline and 4 weeks after inclusion
The King's Sarcoidosis Questionnaire (KSQ)
The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete.
Time frame: baseline and 16 weeks after inclusion
The King's Sarcoidosis Questionnaire (KSQ)
The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete.
Time frame: baseline and 24 weeks after inclusion
The King's Sarcoidosis Questionnaire (KSQ)
The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete.
Time frame: baseline and 1 year after inclusion
The King's Sarcoidosis Questionnaire (KSQ)
The King's Sarcoidosis Questionnaire (KSQ) assesses health status in patients with sarcoidosis. It comprises 29 items in 5 subdomains: general health status, lung, medication, skin and eyes. All scores range from 0 to 100, higher scores signifying beter health status. It takes about 3-5 minutes to complete.
Time frame: baseline and 2 years after inclusion
The Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.
Time frame: baseline
The Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.
Time frame: baseline and 4 weeks after inclusion
The Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.
Time frame: baseline and 16 weeks after inclusion
The Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.
Time frame: baseline and 24 weeks after inclusion
The Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.
Time frame: baseline and 1 year after inclusion
The Chronic Respiratory Questionnaire (CRQ)
The Chronic Respiratory Questionnaire (CRQ) is a 20-item self-reported validated questionnaire for HRQOL in patients with chronic respiratory disease. Scores range from 0 - 100 and higher scores signifying beter health quality.The minimal clinically important difference (MCID) is 0,5 points per item. It takes about 3-5 minutes to complete.
Time frame: baseline and 2 years after inclusion
The global rating of change scale (GRC)
The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \<1 minute to complete.
Time frame: baseline
The global rating of change scale (GRC)
The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \<1 minute to complete.
Time frame: baseline and 4 weeks after inclusion
The global rating of change scale (GRC)
The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \<1 minute to complete.
Time frame: baseline and 16 weeks after inclusion
The global rating of change scale (GRC)
The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \<1 minute to complete.
Time frame: baseline and 24 weeks after inclusion
The global rating of change scale (GRC)
The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \<1 minute to complete.
Time frame: baseline and 1 year after inclusion
The global rating of change scale (GRC)
The global rating of change scale (GRC) is a measure in which patients are asked to rate if their QOL is improved or deteriorated over a certain period of time on a scale from -7 to +7. It consists of one questions and takes \<1 minute to complete.
Time frame: baseline and 2 years after inclusion
The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)
Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL.
Time frame: baseline
The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)
Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL.
Time frame: baseline and 4 weeks after inclusion
The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)
Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL.
Time frame: baseline and 16 weeks after inclusion
The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)
Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL.
Time frame: baseline and 24 weeks after inclusion
The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)
Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL.
Time frame: baseline and 1 year after inclusion
The EuroQol five dimensions 5-level questionnaire (EQ-5D-5L)
Patients will complete the EQ-5D-5L questionnaire, a standardized instrument to measure health outcomes in two components: health description and valuation. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-point scale. From these 5 answers an index value is derived between 0 and 1, with a higher value corresponding with a better QoL. In the valuation part the patients' general health status is evaluated using a VAS-score from 0 to 100, with a higher score representing a better QoL.
Time frame: baseline and 2 years after inclusion
The Medical Research Council Dyspnea scale
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.
Time frame: Baseline
The Medical Research Council Dyspnea scale
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.
Time frame: Baseline and 4 weeks after inclusion
The Medical Research Council Dyspnea scale
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.
Time frame: Baseline and 16 weeks after inclusion
The Medical Research Council Dyspnea scale
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.
Time frame: Baseline and 24 weeks after inclusion
The Medical Research Council Dyspnea scale
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.
Time frame: Baseline and 1 year after inclusion
The Medical Research Council Dyspnea scale
The Medical Research Council Dyspnea scale consists of one question measuring dyspnea on a scale from 0-5.
Time frame: Baseline and 2 years after inclusion
The fatigue assessment scale (FAS)
The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.
Time frame: Baseline
The fatigue assessment scale (FAS)
The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.
Time frame: Baseline and 4 weeks after inclusion
The fatigue assessment scale (FAS)
The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.
Time frame: Baseline and 16 weeks after inclusion
The fatigue assessment scale (FAS)
The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.
Time frame: Baseline and 24 weeks after inclusion
The fatigue assessment scale (FAS)
The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.
Time frame: Baseline and 1 year after inclusion
The fatigue assessment scale (FAS)
The fatigue assessment scale (FAS) is a 10-item self-administered questionnaire about fatigue in patients with sarcoidosis. The score ranges from 5-50 points, with a score of ≥ 22 points as cut-off for fatigue. The MCID is 4 points or a 10% lower score.
Time frame: Baseline and 2 years after inclusion
Number of patients who discontinue/switch medication
Every week patients register whether they missed pills (and the amount of pills wasted). Discontinuation or switch of medication is registered both by patients and researchers.
Time frame: During 24 weeks
Patient Experience and Satisfaction with Medication questionnaire
Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.
Time frame: baseline
Patient Experience and Satisfaction with Medication questionnaire
Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.
Time frame: 4 weeks
Patient Experience and Satisfaction with Medication questionnaire
Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.
Time frame: 16 weeks
Patient Experience and Satisfaction with Medication questionnaire
Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.
Time frame: 24 weeks
Patient Experience and Satisfaction with Medication questionnaire
Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.
Time frame: 1 year
Patient Experience and Satisfaction with Medication questionnaire
Correlation between patient expectations with medication and consecutive experiences measured with the PESaM questionnaire which assess patient expectations at baseline in an 11-item questionnaire and patient experiences and side-effects with medication after 12 weeks in a 26-item questionnaire on a 0-4 Likert scale. For each question it is different whether a higher score represents better or worse outcomes.
Time frame: 2 years