Pharmacovigilance OSF Protocol 6SEPT2016

Utility of social media and crowd-sourced data for
pharmacovigilance
A scoping review protocol
Prepared for Registration to Open Science Framework
Submitted 9/6/2016
Knowledge Translation Program

Li Ka Shing Knowledge Institute
St. Michael’s Hospital
Contact:
Dr. Andrea C. Tricco
E: [email protected]
T: 416-864-6060 ext. 77521
Review title and timescale
1 Review title:
Utility of social media and crowd-sourced data for pharmacovigilance: A scoping review
2 Anticipated or actual start date:
24/05/2016
3 Anticipated completion date:
31/01/2017
4 Stage of review at time of this submission:
This review has not yet started ☐
Review stage (Please check all that apply) Started Completed
Preliminary searches ☐ 
Piloting of the study selection process ☐ 
Formal screening of search results against eligibility criteria ☐ 
Data extraction ☐ 
Risk of bias (quality) assessment ☐ N/A
Data analysis ☐ ☐
Provide any other relevant information about the stage of the review here: Not applicable
Review team details

5 Named contact
Dr. Andrea C. Tricco
6 Named contact email
[email protected]
7 Named contact address
209 Victoria Street, 7th floor, Room 721, East building, Toronto, ON M5B 1T8
8 Named contact phone number
416-864-6060 ext 77521
9 Organisational affiliation of the review
Knowledge Translation Program, Li Ka Shing Knowledge Institute of St. Michael’s Hospital
Website address: http://knowledgetranslation.net/
10 Review team members and their organisational affiliations
Give the title, first name and last name of all members of the team working directly on the review.
Give the organisational affiliations of each member of the review team.
Title First name Last name Affiliation
Dr Andrea Tricco Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Toronto,
Ontario, Canada; Epidemiology Division,
Dalla Lana School of Public Health, University of Toronto,
Toronto, Ontario, Canada
Ms Wasifa Zarin Knowledge Translation Program, Li Ka Shing Knowledge Institute
of St. Michael’s Hospital
Adapted from the registration form for the PROSPERO database. 1

Ms Erin Lillie Knowledge Translation Program, Li Ka Shing Knowledge Institute
Dr. Ba’ Pham Knowledge Translation Program, Li Ka Shing Knowledge Institute
Dr. Sharon Straus Knowledge Translation Program, Li Ka Shing Knowledge Institute
of St. Michael’s Hospital, Department of Medicine, Faculty of
Medicine, University of Toronto
11 Funding sources/sponsors
Drug Safety and Effectiveness Network of Health Canada
12 Conflicts of interest
Authors have no known conflicts of interest to declare.
Review methods
13 Review question(s):
This scoping review aims to assess the utility of social media and crowd-sourced data to monitor
and detect adverse events related to health products. The specific research questions are:
(1) What social listening and analytics platforms exist internationally to detect adverse events related
to health products using social media and crowd-sourced data? What are their capabilities and
characteristics?
(2) What is the validity of user-generated data from social media for surveillance of adverse events
to health products?
14 Literature Search:
Comprehensive literature searches of electronic bibliographic databases were conducted by an
experienced librarian in MEDLINE, EMBASE, and the Cochrane Library. The search strategy was
peer-reviewed by another expert librarian using the PRESS (Peer Review of Electronic Search
Strategies) checklist. A grey literature search for unpublished and difficult to locate studies was
conducted according to the CADTH guide. Specifically, we searched 59 grey literature sources and
websites of approximately 119 relevant regulatory authorities for additional publications or pre-
existing platforms of social media listening and data analytics (e.g., FDA MedWatcher Social, WEB-
RADR). We also scanned the reference lists of all relevant reviews.
15 URL to search strategy:
Not applicable
16 Condition or domain being studied:
Social media listening for surveillance of adverse events related to health products.
17 Participants/Population:
Patients of all ages with an adverse event related to health products which includes pharmaceuticals
and drug products, biologics, medical devices and natural health products. Examples of
pharmaceuticals and drug products include both prescription and non-prescription (over-the-counter)
medicines, disinfectants and sanitizers with disinfectant claims. Biologics can include, but are not
limited to: vaccines, insulin, serums, blood-derived products, hormones, growth factors and
enzymes manufactured in bacterial, yeast or mammalian cell lines; and gene therapy and cell
therapy products. Medical devices can include defibrillators, syringes, surgical lasers, hip implants,
medical laboratory diagnostic instruments (including X-ray, ultrasound devices), contact lenses, and
condoms. Natural health products can include vitamins and minerals, herbal remedies, homeopathic

and traditional medicines, probiotics, and other products like amino acids and essential fatty acids.
Adverse events, such as addiction and overdose from prescription medical products are also eligible
for inclusion. Adverse events related to programs of care, health services, organization of care,
public health programs, health promotion programs, and health education programs were excluded.
18 Intervention(s)/Exposure(s):
Any data analytics or social listening platforms that enable the extraction of user-generated and
crowd-sourced data about adverse events to health products from social media. Social media
technology is defined as a web-based application that allows for the creation and exchange of user-
generated content. This includes, but is not limited to: websites, web pages, blogs, vlogs, social
networks, Internet forums, chat rooms, wikis, and smartphone applications, where users have the
ability to generate content (typically by providing posts and comments, often in an anonymous
fashion or with limited identifying information) and are able to view/exchange content from and with
others in an interactive digital environment. Crowd-sourcing is the practice of obtaining needed
services, ideas, or content by soliciting contributions from a large group of people and especially
from the online community rather than from traditional employees or suppliers. Social media
listening and data analytics for public health surveillance related to non-communicable (e.g., disease
prevalence) and communicable diseases (e.g., outbreak investigation) will be excluded.
19 Comparator(s)/Control(s):
Any comparator is relevant for inclusion, such as studies comparing one form of social media or
crowd-sourced data to another or comparing social media with traditional reporting systems. In
addition, studies without a comparator are eligible for inclusion.
20 Types of study to be included initially:
All types of publications including published articles, articles in conference proceedings, editorials,
websites, and chapters in textbooks are relevant.
21 Context:
All periods of time and duration of follow-up are eligible.
22 Primary outcome(s):
There are two broad categories of outcomes that are of interest: (1) characteristics of social media
listening and analytics platform (e.g., data sources, scope of surveillance, capabilities, data
extraction, preprocessing data, annotation, text mining methods, computational frameworks, added
value to existing surveillance capacities, technical skills required, infrastructure support to implement
and sustain, privacy and security of the data); and, (2) validity of user-generated data through social
media and crowd-sourcing networks (e.g., relationship between health technologies and adverse
events, algorithms or processes used to validate the data, and related results of the evaluation).
23 Secondary outcome(s):
Not applicable
24 Data extraction (selection and coding):
Using the a priori eligibility criteria, a standardized questionnaire for study selection was developed
for screening of titles and abstracts and full-text articles. A training exercise preceded each level of
screening. Subsequently, pairs of reviewers screened citations and full-text articles for inclusion,
independently. Inter-rater discrepancies were resolved by discussion or a third adjudicator. We
abstracted data on characteristics of the articles (e.g., type of article or study, country of
corresponding author), population characteristics (e.g., type of patients, type of adverse events,
disease condition), intervention characteristics (e.g., type of social media or crowd-sourced data
used), and outcomes (e.g., platform characteristics, data analytics used, validity of social media or
crowd-sourced data). A standardized data abstraction was developed and pilot-tested among all
reviewers.. Subsequently, all included studies were abstracted by one reviewer and verified by an

experienced study coordinator.
25 Risk of bias (quality) assessment:
Since this is a scoping review, we will not conduct quality appraisal, which is consistent with the
framework proposed by Arksey and O’Malley, as well as the Joanna Briggs Institute methodological
guidance for Scoping Reviews.
26 Strategy for data synthesis:
The synthesis will focus on providing: 1) a description of platforms that exist internationally, and 2)
the validity of data from these platforms. This will be achieved by summarizing the literature
according to the types of participants, interventions, comparators, and outcomes identified.
Quantitative analysis will be conducted using descriptive methods (i.e., frequencies, summary
statistics). As well, we will consider qualitative analysis (e.g., content analysis) for open-text data, as
necessary, which will be conducted by two reviewers independently, using NVivo software.
27 Analysis of subgroups or subsets:
Not applicable
Review general information

28 Type of review
Select one of the following:
Review Type
Scoping review 
Rapid review ☐
Systematic review ☐
Other:____________ ☐
29 Language
English
30 Country
Canada
31 Other registration details
Not applicable
32 Reference and/or URL for published protocol
Submitted to BMJ Open for publication. Awaiting peer-reviewed feedback.
33 Dissemination plans:
The summary of results will be sent to Health Canada and other relevant policy-makers and
researchers working with the Drug Safety and Effective Network in the form of a 1-page policy brief
(link for an example). As well, a 1-day stakeholder meeting (i.e., consultation exercise) will be held
to discuss the implications of our scoping review, key messages, and to finalize the knowledge
translation strategy. All relevant stakeholders will be invited to attend, as recommended by members
from the Health Canada Health Products and Food Branch. This meeting will be essential to ensure
extensive knowledge translation of our findings and to engage stakeholders and promote our
research agenda. We will also present our results at an international conference and publish in an
open-access journal. Finally, team members will use their networks to encourage broad
dissemination of results.

Do you intend to publish the review on completion?
Yes 
No ☐
34 Keywords
surveillance, adverse event, scoping review, social media, data analytics, social listening
35 Details of any existing review of the same topic by the same authors.
Not applicable
36 Current review status
Ongoing (data cleaning phase)
37 Any additional information:
Not applicable
38 Details of final report/publication(s):
Note applicable (review still in progress)

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Utility of social media and crowd-sourced data for

A scoping review protocol

Prepared for Registration to Open Science Framework

Knowledge Translation Program

Review team details

Adapted from the registration form for the PROSPERO database. 1

Adapted from the registration form for the PROSPERO database. 2

Adapted from the registration form for the PROSPERO database. 3

Review general information

Adapted from the registration form for the PROSPERO database. 4

Adapted from the registration form for the PROSPERO database. 5

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