This mixed-method systematic review protocol is designed based on PRISMA-P statement11 and follows the methodological approach proposed in the Cochrane handbook for conducting systematic reviews12.
2.1 Eligibility criteria
Type of studies: All empirical studies (quantitative, qualitative, mixed methods) on the proposed devices for the detection of any type of seizures (focal or generalized; motor or non-motor; unknown) for any outcome measured (e.g., validity for seizure detection, number of seizures, patient satisfaction, etc.) will be considered. All studies from database creation up to 2019 will be included. All languages will be included. Exclusion criteria: editorials, comments, letters to the editor and technical memo. Conditions or domains being studied: This systematic review is positioned in the field of epilepsy, seizures, epilepsy treatment and management, effect on QoL of epilepsy, and the prevention of seizure-related adverse events through technology. Its main purpose is to identify currently available solutions.
This systematic review also focuses on the needs, perceptions and attitudes towards the use of portable technologies for tracking seizures in people living with epilepsy, their professionals or informal caregivers and healthcare professionals. Moreover, the review will identify the perceived motivators and factors influencing the use or non-use of these technologies. Type of participants: Patients with a diagnostic of epilepsy (every type). Type of interventions: Studies assessing any type of portable technology used for detecting epilepsy seizures. Comparator(s)/control: The reference group will not have any intervention or will get other methods for detecting seizures (not based on information and communication technologies, e.g., standard EEG).
2.2 Information sources
We developed a search strategy that will be used for MEDLINE [PubMed, 1951-June 2019], EMBASE [OVID, 1947-June 2019] and the Cochrane Register of Controlled Trails (CENTRAL) [up to June 2019]. We will identify randomized controlled trials by validated filters for MEDLINE and EMBASE. We will conduct similar research in Web of Science and CINAHL. We will also consider grey literature and ongoing studies by searching Google and specialized sites on epilepsy.
2.3 Search strategy (see Appendix 1)
The MEDLINE strategy is presented in Appendix 1. A similar search will be conducted with EMBASE, CENTRAL, The Cochrane Library, CINAHL, and the Web of Science.
2.4 Study records
2.4.1 Data management
Records and data will be exported to Rayyan 13 directly from databases for the selection process.
2.4.2 Selection process
The selection process will be done by two authors independently through each phase of the review (screening, eligibility and inclusion in meta-analysis). We will merge search results by using EndNote X8 and remove duplicate records of the same report. First, we will examine titles and remove obviously irrelevant reports. Second, we will review abstracts and we will retrieve full text of the potentially relevant reports. We will examine full-text reports for compliance of studies with eligibility criteria. We will review the selected studies and make final decisions on inclusion and proceed to data extraction.
2.4.3 Data collection process
We will create a data abstraction form using Excel to standardize the data collection process, which will be pilot tested. Data will be collected independently by the same two authors previously identified. We will compare the results of both data extraction. Electronic searches for text will aid to locate useful data. A translator will be contacted for studies published in languages other than English or French.
2.5 Data items
We will gather: (1) characteristics of the studies selected (year, author, country, design, method and follow-up); (2) Demographic data of the population included in the studies assessed (age, diagnosis, sex, comorbidities); (3) Individual information (type of epilepsy, hospitalization time, e-Health solutions used, number of seizures, performance assessment (sensitivity, specificity). We will present the results in a narrative form.
2.6 Outcomes and prioritization
Prioritized outcomes of this systematic review are the effects of the technologies on the health and the quality of life of the patients with epilepsy. We will also take into account the validity of the measures, the number of hospitalisations due to relapse, the duration of hospital stays, and costs related to the intervention.
The secondary outcomes will include knowledge of e-Health solutions and health behaviors of all participant groups and perceived social support specifically for the epileptic participant group. We will also include the perceptions and needs of all participant groups regarding e-Health solutions, as well as the perceived motivators and barriers for use or non-use of e-Health solutions in all participant groups. Comparing the performance of various devices will be another secondary outcome.
2.7 Risk of bias in individual studies
The risk of bias will be assessed independently by the two reviewers. At the study level, we use the Cochrane Collaboration’s Tool for assessing risk of bias (RoB) for randomized controlled trial (RCT). We will use the Risk of Bias in Non-randomized Studies of interventions (ROBINS-I) tool from Cochrane to evaluate the presence of bias in non-randomized trails, the CERQUAL for qualitative studies and the MMAT for the mixed-methods. Although blinding will likely not be possible as participants and providers will know what technology they are using, data analysts should be blinded to the intervention. Attention will be put towards intervention, selection and attrition bias.
2.8 Data Synthesis
Two independent reviewers will analyze data from included studies in Review Manager (Rev-Man) version 5.3. Summary data for each intervention group will be separately collected and entered in Rev-Man. Mean differences (MD) and standardized mean differences (SMD) with 95% confidence intervals will be used to compare scores. Cochran-Mantel-Haenszel method will be used for dichotomous variables9. Subgroup analysis will include type of technology used (e.g. smart watches, smart clothing, tactile mattresses, accelerometers, microphones and cameras).