40 CHAPTER 2 All participants are not allowed to participate in any other scientific study that might interfere with their participation in the NA-CONTROL study (from signing informed consent to completing the follow-up from home). Post-trial care If deemed necessary by the treating clinician and desired by the patient, the treatment can be extended after the 9 sessions that are part of the experimental intervention. Data collection and management Data collection Data will be collected as described under outcomes. The assessor (the coordinating researcher) conducting the measurements is trained in collecting all measures that are obtained during the measurement protocol (i.e. operating MRI systems, applying bipolar EMG surface electrodes, conducting force measurements, palpating bony landmarks of the scapula and trunk, etc.). Data management system Most data is collected through lab based measurement systems, or entered directly in the electronic CRF in a GCP compliant electronic data management system (castor EDC, www.castoredc.com). This system utilises a log system with an automated audit trail. The Delegation of Responsibilities Log will identify all individuals responsible for data collection, handling and managing of the database. A data management plan, detailing location of and access to study data and the code list, method of coding, back-up, locking, and archiving of data, code list and analysis files has been submitted to and approved by the Board of Directors of the Radboudumc. Statistics and data analysis Proposed analysis For all continuous variables, summaries will be given, reporting number of (missing) observations, mean, standard deviation, median and range. For categorical variables, the summaries will report number of (missing) observations, and number and percentage in each category. This will be done for each time point (baseline, outcome measurement(s) and follow-up), and for the change from baseline for each intervention group separately. The primary clinical outcome (SRQ-DLV score) and most other clinical outcomes are linear or quasi-linear. Generalised estimated equations analysis will be employed to investigate group differences in the intervention effects on primary and secondary outcomemeasures and to investigate the influence of possible effect modifiers. If necessary, analyses will be adjusted for group differences in functional capability of the upper extremity (SRQ-DLV score), age and sex at baseline. Data will be analysed according to the intention to treat principle. If necessary to satisfy modelling assumptions, appropriate transformations will be performed. Prior to locking of the data, a statistical analysis plan will be drawn up and approved by a statistician and the principal investigator.
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