Page 158 - THE EVOLUTION OF EARLY ARTHRITIS AND CARDIOVASCULAR RISK Samina A. Turk

CHAPTER 8
PATIENTS AND METHODS
Study population
All newly diagnosed RA patients (ACR/EULAR 2010 criteria (10)) aged 18 years or above with a disease duration of less than two years, and either high disease activity or unfavourable prognostic factors, were invited to participate in this study. Recruitment took place in the outpatient rheumatology department of the Amsterdam Rheumatology and immunology Center, locations VU University medical center and Reade, the Netherlands. Treatment according to a treat-to-target regime comprised initial methotrexate and step-down prednisolone; if good EULAR response was not achieved after 13 weeks, patients were randomized to continue treatment or intensify treatment. Exclusion criteria were: a history of DMARD use, the use of >7.5 mg/day of glucocorticoids in the past four weeks, or fulfilling any contra-indications for the use of the study medication. All patients that had completed the week 26 visit in January 2016 were eligible for inclusion in the current study.
This study was approved by the local Ethics Committee and qualified as a study carrying no extra risk for the participants. All patients received written information about the study and provided informed consent for their participation.
Measurements
Measurements took place at baseline and after 13 and 26 weeks of treatment, and included:
• The normality scale
The ‘normality scale’, developed in 2009, is a questionnaire that measures the perception of normality in RA patients in 7 items (Figure 1, column A) (9). The items were derived from interviews with RA patients about living with their chronic condition (11). The scale was translated from English to Dutch by two separate forward and backward translations. This resulted in the final Dutch version used for this study (Figure 1, column B). All items were scored on a 5-point Likert scale: 1 for strongly disagree and 5 for strongly agree for items 1 and 3-7; reverse scoring for item 2. Simple addition leads to a total score that ranges between 7 and 35, with higher scores indicating a higher feeling of normality.
• Disease activity
The WHO-ILAR core set (12) evaluated disease activity. Joints were assessed by a trained researcher or (research) nurse. PtGA as well as assessor global assessment (AssGA) and patient pain were expressed on a 0-100 scale. Since the PhGA was not assessed at all time points, AssGA was used instead. The AssGA is similar to the PhGA, only assessed by the researcher or (research) nurse instead of the physician. Physical functioning was assessed with the Health Assessment Questionnaire (HAQ). Disease Activity Score of 44 joints (DAS44) was calculated, which was converted to the Disease Activity Score
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