Objective Digital tools offer new ways of collecting outcome data in intervention research. Little is known about the potentials and barriers of using such tools for outcome measurement in multiple sclerosis trials. This study aimed to examine reporting adherence and barriers experienced by people with multiple sclerosis in an intervention study using three different digital tools for outcome measurement. Methods This was a mixed-methods study conducted in the context of a randomized controlled trial. Data collected during the randomized controlled trial were analysed to assess reporting adherence. Twenty-three semi-structured, in-depth interviews were conducted to investigate randomized controlled trial participants’ experiences. Results Reporting adherence was high for all three measurement tools, but lower in the control group. Four main barriers were defined: (1) the self-monitoring aspect and repeated tests imbedded in the digital tools affected participants’ behavior during the randomized controlled trial. (2) Self-monitoring caused some participants to worry more about their health. (3) Passively collected data did not always correspond with participants’ own experiences, which caused them to question the validity of the collected data. (4) Daily reporting using different digital tools placed a significant burden on participants. Conclusion The study indicates a high reporting adherence using digital tools among people with multiple sclerosis. However, future studies should carefully consider the overall burden imposed on participants when taking this approach. Measures should be taken to avoid the potential unintended effects of the self-monitoring and gamification aspects of using digital tools. These measures could include passive monitoring, reducing the frequency of reporting and blinding participants to their own data.

Background and aim Multiple sclerosis (MS) is characterized by increasing symptom burden leading many people with MS to use complementary treatments. TRE (Tension and Trauma Releasing Exercises) is a mind-body therapeutic method aiming to release muscle tension and stress. People with MS (PwMS) have reported benefits from TRE, but no scientific studies have investigated the effects of TRE on PwMS. Aim: To test a TRE program for PwMS and thereby explore outcome measures to be applied in future randomized studies. Experimental procedure A nine-week TRE program was completed by nine participants: Five were women, age ranged from 44 to 66 years, and time since diagnosis ranged from 2 to 21 years. Outcome measures included self-reported day-to-day levels of nine different symptoms as well as sleep quality and stress level. Modified Fatigue Impact Scale (MFIS) fatigue score and spasticity level of the ankle plantar flexors, assessed using a Portable Spasticity Assessment Device (PSAD), were measured pre and post intervention. Results Decreases were seen in the mean scores of all nine self-reported day-to-day symptoms as well as stress level, while sleep quality mean score increased. LME analyses showed that all changes were statistically significant except one (bowel dysfunction). Mean MFIS-measured fatigue level decreased significantly from a score of 43.7 (SD = 13.6) to a score of 22.0 (SD = 12.3). No significant change was reported in PSAD-measured spasticity level. Conclusion The study indicates possible effects of TRE on PwMS on several self-reported outcome measures. Larger, randomized studies should be carried out to explore the findings further.

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