Executability and repeatability of a study setup using wearable and computerized technology to examine a wide range of physiological and cognitive functions of a patient outside hospital

Objectives Reasons for a patient’s daily problems are often unclear as they are not systematically monitored in daily life. To remedy this, we designed a study protocol combining outpatient laboratory and home measurements. Feasibility of the protocol was evaluated by examining its executability and repeatability. Participants Sixteen patients undergoing neurosurgery for unruptured intracranial aneurysm (UIA), each acting as one’s own control. Study Protocol Two laboratory examinations followed by home recordings at 2 weeks pre- and 4-6 weeks postoperatively. In between a sole home recording at 3 weeks and 3 months postoperatively. Subjective health and performance data were gathered via an internet portal. Methods Laboratory Day included computer-based cognitive tests on attention, working memory and executive functions. Electroencephalography (EEG), electrocardiography (ECG) and electrodermal activity (EDA) were recorded during the tests. A saccade test with electro-oculography (EOG) and event-related potentials (ERP) to emotionally loaded sounds were also done. First three home recordings included tablet-based cognitive tests, sleep polysomnography (PSG), ECG, and actigraphy; the 4th only an actigraphy and sleep diary. Outcome measures Executability and repeatability of the protocol: Number of patients completing the study, success rate of carrying it out as planned, obtained data and patient feedback. Results In 13 (81%) patients all data from home recordings was obtained as planned. In 11 (68%) patients the whole protocol was carried out as planned and in 3 partly. The time schedules required adjusting. Patients reported no discomfort from using wearable devices. Patients considered answering the internet-based health questionnaires cumbersome: all data was obtained only in 30%. Conclusions Mobile technologies are a tool kit from which to choose a clinically relevant combination to obtain objective data on a patient’s physical, physiologic, and cognitive performance outside hospital. Strengths Limitations ### Competing Interest Statement Aaro Mustonen and Tuomas Tikka work at BCB Medical. Kiti Muller worked at Nokia Technologies and Bell Labs from November 2014 to May 2020. Kiti Muller works as part time Senior Medical Advisor at GlucoModicum. ### Funding Statement This study was supported by Business Finland Grant 1939/31/2015 Seamless Patient Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study followed ethical principles of the Declaration of Helsinki and was approved by the Ethics Committee of Helsinki and Uusimaa Hospital District (38/13/03/00/2016). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The data gathered during this research is anonymised and stored in a data repository at Helsinki University Central Hospital. This paper describes only outcome data relevant for evaluating the executability and reproducibility of the study protocol.