What do we collect data on?
At each study visit, the research team will collect information related to your disease. Much of this information collected will be the same as routine clinical data collected during patient assessments in clinic. This includes weight, current medication, a physical examination and a blood and urine sample for standard tests. We monitor the data collected to check for any missing, unexpected or unusual values.
We will also assess a patients modified Rodnan Skin Score (mRSS). This scoring system involves an assessment of the skin at 17 sites across the body. Each site is graded between 0 and 3, with 0 indicating normal skin and 3 indicating severely thickened skin. The scores at each site are then added up, with a maximum total possible score of 51. The mRSS is currently the ‘gold standard’ method of assessing disease severity in systemic sclerosis and it is widely used both in routine clinical assessments and in controlled clinical trials. All participating centres have extensive experience in skin scoring as leading specialist centres.
Patients participating in PRedSS are also asked to complete a set of questionnaires at each of their visits. This will take approximately 25 minutes each time. These questionnaires will ask questions about how patients are feeling and assess the level of pain and disability due to scleroderm. Each questionnaire has been extensively validated and each is provided with a set of instructions. The questionnaires provide us with scores, which are an important part of the statistical analysis of the study by the University of Manchester.
Blood and urine samples will also be collected for future scleroderma research projects. The analysis of these samples will not be part of the results of the PRedSS study. Click here for more information.
Are there any other activities outside the study visits?
The study doctor will also ask patients to measure their blood pressure twice a week. This is a common test that a GP often records. Patients are asked to monitor blood pressure for safety and convenience, but this is not compulsory. The study doctor or research nurse will explain and show patients how to measure their own blood pressure. If patients experience any problems taking this measurement, a member of the research team will be more than happy to help.
Patients will also be given a study diary to take home to record blood pressure readings in, and also how many capsules patients take each day. Patients will also be issued with a PRedSS steroid card which they must carry with them at all times.
When does participation in the study stop?
Patients will receive a total of 6 months treatment. Participation in the PRedSS study will stop at the end of Visit 5 and patients will return to standard care. All patients will be told which study treatment they have been taking and the treatment course that should now be followed will be suggested. The study doctor will recommend that patients see the hospital doctor within 30 days.