Patient-generated data in epilepsy care decisions: a scoping review protocol : JBI Evidence Synthesis

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Patient-generated data in epilepsy care decisions: a scoping review protocol

Jylhä, Virpi1,2; Rosenlund, Milla1,2; Kuusisto, Hanna1,3; Saranto, Kaija1,2

Author Information
JBI Evidence Synthesis 20(6):p 1578-1584, June 2022. | DOI: 10.11124/JBIES-21-00195
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Epilepsy is one of the most common serious neurological disorders affecting people of all ages.1,2 In addition to seizures, people with epilepsy may have neurological, psychiatric, cognitive, or social difficulties. Epilepsy may affect one's ability to work, drive, study, or start a family, significantly affecting quality of life.3,4 Epilepsy has a substantial impact on socioeconomic burden, of which more than half is caused by indirect costs, such as early retirement, sick leave, or death. Of these costs, 80% is caused by drug-resistant epilepsy.5 There are more than 20 antiepileptic drugs (AEDs) from which to choose. Although the variety is great, approximately every third patient does not achieve seizure freedom after two tolerated and appropriately chosen and applied AEDs, thereby fulfilling the criteria of drug-resistant epilepsy.6 Epilepsy is a typical preference-sensitive condition as there are multiple appropriate treatment options. The best and most effective option is the one that reflects what is most important to a well-informed patient.

Patient-centeredness, defined as “providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions,” is an essential component of high-quality health care services.7(p.40) It encourages health care professionals to integrate patients more actively into decisionmaking about treatment choices. It is expected that patients who involve themselves in care decisions will experience better health outcomes and satisfaction, especially when making long-term decisions in the context of chronic diseases.8 One previous systematic review showed that the majority of patients studied preferred sharing decision roles in clinical decision-making.9 However, the competence of both health care professionals and the patients themselves to conduct effective and appropriate care decision-making is associated with high-quality information. Furthermore, health information has a central role in decision-making, which becomes evident in communication between patients and health care professionals. Information about treatment options suitable for the patient in question, the context in which the care is delivered, and patients’ preferences together with health professionals’ experience all affect the decisions made.

Decisions about the management of long-term conditions such as epilepsy are based on multiple factors, including efficacy and safety of interventions as well as the patient's status and preferences. As the same care intervention may have very different meanings in different people's lives, patient-generated data are meaningful when treating patients with preference-sensitive conditions. Patient-generated data integrate patient values and preferences into care decision-making. Such data can be defined as any health data generated by a patient, such as symptoms, treatment history, patient-reported outcomes and experiences, biometric data, and patient values and preferences.10,11 The latter include life choices, preferred treatment, and opinions about different features of interventions. The specific characteristic of patient-generated data is that patients take responsibility for generating the data, and they control how they share the data. However, the lack of identification of health professionals’ information needs in terms of patient-generated data hampers integration of the data into clinical use. There are challenges concerning the accuracy, reliability, completeness, context, patient motivation, and representation of that data, leading to information quality problems.11 Another challenge is the level of information literacy of patients and their ability to produce relevant data and participate in decision-making.

The objective of this scoping review is to explore the meaning and content of patient-generated data in epilepsy care decisions. As the topic has not been very widely studied, different research methodologies may yield valuable information concerning the topic. Moreover, as our primary aim is to describe the concept of patient-generated data, the reviewers agreed to conduct a scoping review. This scoping review will provide an overview of the evidence and identify the range of information types and needs in terms of patient-generated data in epilepsy care decisions. A preliminary search of PROSPERO, MEDLINE, the Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis was conducted and no published or currently in-progress systematic reviews or scoping reviews on the topic were identified. To our knowledge, this will be the first scoping review to explore the extent of the literature and map the research findings on the meaning and content of patient-generated data in epilepsy care decisions.

Review questions

What is the meaning and content of patient-generated data in epilepsy care decisions?

  • i. What information do patients with epilepsy produce for making care decisions?
  • ii. What patient-generated data do health care professionals need in decision-making?
  • iii. How are the patient-generated data produced?
  • iv. What issues of information quality have been discussed?

Inclusion criteria


This review will consider studies that include adult patients with epilepsy, and when needed, their family members or guardians who act on their behalf, and/or health professionals who treat adult patients with epilepsy.


This review will consider studies that explore or describe patient-generated data, including patient preferences and values in decision-making situations. Patient-generated data include any health data obtained from a patient, such as preferences and values, symptoms, lifestyle choices, patient-reported outcomes and experiences, and treatment history. The data can be in electronic or paper format and it can be collected, for example, through validated forms, self-tracking devices, mobile applications, personal health records, verbally, through private chats, or written manually on paper. Identified quality problems can be related to the accuracy, reliability, completeness, context, patient motivation, and representation of that data.


This review will consider studies focusing on clinical decision-making. Any care decisions in which the patient is actively involved and generates health data in any health care facility, including eHealth services, will be considered. Both outpatient and inpatient clinics will be considered.

Types of sources

This scoping review will consider both experimental and quasi-experimental study designs, including randomized controlled trials, non-randomized controlled trials, before and after studies, and interrupted time-series studies. In addition, analytical observational studies, including prospective and retrospective cohort studies, case-control studies, and analytical cross-sectional studies will be considered for inclusion. This review will also consider descriptive observational study designs including case series, individual case reports, and descriptive cross-sectional studies.

Qualitative studies will also be considered if they focus on qualitative data, including, but not limited to, designs such as phenomenology, grounded theory, ethnography, qualitative description, action research, and feminist research. In addition, systematic reviews meeting the inclusion criteria will be considered, depending on the research question. Text and opinion papers will also be considered for inclusion in this scoping review. Systematic review and trial protocols will be excluded.


The proposed scoping review will be conducted in accordance with the JBI methodology for scoping reviews,12,13 and will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).14

Search strategy

The search strategy will aim to locate both published and unpublished studies. An initial limited search of MEDLINE (PubMed) and CINAHL (EBSCO) was undertaken to identify articles on the topic. The text words contained in the titles and abstracts of relevant articles, and the index terms used to describe the articles, were used to develop a full search strategy for MEDLINE (PubMed) (see Appendix I). The search strategy, including all identified keywords and index terms, will be adapted for each included database and/or information source. The reference lists of all included sources of evidence will be screened for additional studies. The expertise of library information specialists has been utilized in developing the search strategy.

All published studies without time limit will be considered for inclusion in this review. Studies published in English, Finnish, Swedish, and German will be included. Studies published in other languages will be excluded due to feasibility (eg, expense of full translations).

The initial keywords to be used will include “epilepsy,” “patient-generated,” and “decision-making,” with their synonyms and related terms (see Table 1).

Table 1 - Initial keywords to be used in search strategy
Participants Concept Context
Epilepsy (Mesh) Patient generated OR Decision making OR
Epilepsy Patient preference(s) OR Decision making (Mesh) OR
Epilepsies Patient preference (Mesh) OR Clinical Decision making (Mesh) OR
Seizure disorder(s) Patient values OR Shared decision making OR
Patient perspective OR Decision Making, shared (Mesh) OR
Patient views Patient participation OR
Patient participation (Mesh) OR
Patient engagement OR
Collaborative decision-making OR
Participatory medicine OR

The databases to be searched include MEDLINE (PubMed), CINAHL (EBSCO), Scopus, PsycINFO (EBSCO), and Cochrane Central Register of Controlled Trials. Sources of unpublished studies or gray literature to be searched include websites of relevant organizations such as Epilepsy Society, the International League Against Epilepsy, the International Bureau of Epilepsy for Epilepsy, and DART-Europe E-theses Portal.

Source of evidence selection

Following the search, all identified citations will be collated and uploaded into Covidence Systematic Review Software (Veritas Health Innovation, Melbourne, Australia) and duplicates removed. Following a pilot test, titles and abstracts will be screened by two independent reviewers for assessment against the inclusion criteria. Potentially relevant sources will be retrieved in full, and their citation details imported into the JBI System for the Unified Management, Assessment and Review of Information (JBI SUMARI; JBI, Adelaide, Australia). The full text of selected citations will be assessed in detail against the inclusion criteria by two independent reviewers. Reasons for exclusion of sources of evidence at full text that do not meet the inclusion criteria will be recorded and reported in the scoping review. Any disagreements that arise between the reviewers at each stage of the selection process will be resolved through discussion or with additional reviewers. The results of the search and the study inclusion process will be reported in full in the final scoping review and presented in a PRISMA flow diagram.15

Data extraction

Data will be extracted from papers included in the scoping review by two independent reviewers using a data extraction tool developed by the reviewers. The data extracted will include study-specific information (title, year of publication, corresponding author, country), specific details about the participants, health care setting, study type, methods, and key findings relevant to the review questions, including information types that patients and health care professionals consider to be important as well as recognized quality issues.

A draft extraction form is provided in Appendix II. The draft data extraction tool will be piloted on two to three studies. Based on the piloting, the extraction tool will be modified and revised as necessary before commencing data extraction from each included evidence source. Modifications will be detailed in the review. Any disagreements that arise between the reviewers will be resolved through discussion or with additional reviewers. If appropriate, authors of papers will be contacted to request missing or additional data.

Data analysis and presentation

The results section of this scoping review will contain two sections. The first will describe the results of the search strategy and selection process as well as the characteristics of the included studies. The second section will provide the key information relevant to the review questions. Characteristics of the studies will be described using frequency counts and presented in tables and graphs. We will map the key findings on the meaning of patient-generated data in decision-making. Furthermore, we will classify the content of patient-generated data into categories based on information type. We will classify the quality issues discussed under the following categories: accuracy, reliability, completeness, context, patient motivation, and representation of the data.11 The results will be presented in tabular format. A narrative summary will accompany the tables or graphically depicted results, describing how the results relate to the review objective and questions.


Library Information Specialist Maarit Putous from the University of Eastern Finland Library for her help in designing the search strategy.


This research was funded by the Strategic Research Council (SRC) no: 335288.

Appendix I: Search strategy


Search conducted on October 8, 2021.


Appendix II: Data extraction instrument



1. Sander JW. The epidemiology of epilepsy revisited. Curr Opin Neurol 2003;16 (2):165–170.
2. Kotsopoulos I, de Krom M, Kessels F, Lodder J, Troost J, Twellaar M, et al. Incidence of epilepsy and predictive factors of epileptic and non-epileptic seizures. Seizure 2005;14 (3):175–182.
3. Deuschl G, Beghi E, Fazekas F, Varga T, Christoforidi KA, Sipido E, et al. The burden of neurological diseases in Europe: an analysis for the global burden of disease study 2017. Lancet Public Health 2020;5 (10):e551–e567.
4. Nevalainen O, Simola M, Ansakorpi H, Raitanen J, Artama J, Isojarvi, et al. Epilepsy, excess deaths and years of life lost from external causes. Eur J Epidemiol 2016;31 (5):445–453.
5. Sillanpaa M, Andlin-Sobocki P, Lonnqvist J. Costs of brain disorders in Finland. Acta Neurol Scand 2008;117 (3):167–172.
6. Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc task force of the ILAE commission on therapeutic strategies. Epilepsia 2010;51 (6):1069–1077.
7. Institute of Medicine (US) Committee on Quality of Health Care in America. Improving the 21st-century health care system. In: Institute of Medicine (US) Committee on Quality of Health Care in America, ed. Crossing the quality chasm: a new health system for the 21st century [internet]. Washington DC: Academies Press. 2001 [cited 2021 May 19]. Available from:
8. Joosten EAG, DeFuentes-Merillas L, de Weert GH, Sensky T, van der Staak CPF, de Jong CAJ. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom 2008;77 (4):219–226.
9. Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns 2012;86 (1):9–18.
10. Adler-Milstein J, Nong P. Early experiences with patient generated health data: health system and patient perspectives. J Am Med Inform Assoc 2019;26 (10):952–959.
11. West P, Van Kleek M, Giordano R, Weal M, Shadbolt N. Information quality challenges of patient-generated data in clinical practice. Front Public Health 2017;5:284.
12. Peters MDJ, Godfrey C, McInerney P, Munn Z, Tricco AC, Khalil H. Chapter 11: Scoping reviews. In: Aromataris E, Munn Z, editors. JBI Manual for Evidence Synthesis [internet]. Adelaide: JBI, 2020. [cited 2021 May 19]. Available from:
13. Peters MDJ, Marnie C, Tricco AC, Pollock D, Munn Z, Alexander L, et al. Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synth 2020;18 (10):2119–2126.
14. Tricco AC, Lillie E, Zarin W, O’Brien KK, Colquhoun H, Levac D, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation. Ann Intern Med 2018;169 (7):467–473.
15. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.

clinical decision-making; epilepsy management; information needs; patient-generated data; patient preferences and values

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