Scopus Help Guide

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Table of Contents

Database information: scopus, searching scopus.

  • Accessing Full Text
  • Exporting Results from Scopus

Saving Results/Personal Account in Scopus

Auto alerts in scopus, scopus tutorials.

Scopus and Manifold

Scopus is an extensive abstract and citation database that provides comprehensive coverage of peer-reviewed journals, books, conference abstracts, and patents across the natural sciences, social sciences, arts, and humanities. Using Scopus, you can:

Create customized searches for peer-reviewed literature across many disciplines

  • View citations to journal articles
  • Access the full text of documents provided by subscriptions through the University Libraries
  • View profiles for authors indexed by Scopus, which include measures of scholarly impact like h-index and publication counts

This wealth of available data makes Scopus useful for searching for literature that can help you with your research and determining the impact of scholarly works. 

Searching in Scopus

You can search Scopus for documents, authors, and affiliations, as well as create advanced searches customized to your needs.

Searching for documents On the Scopus home page, you can search for documents based on search terms provided in article titles, keywords, publication names, and many other facets. To begin, enter your search terms in the field provided and use the dropdown box to specify which fields to search.   

Scopus Search Page

You can repeat this process to include additional search terms in different fields. You also have the option to specify date range, document type, and subject areas for the returned results. When you complete your search, the results are presented in a list as shown below.

Scopus Search Results

From this view, you can sort results, refine the results, export and download records, and access complete records for publications. Clicking on a result title opens the full Scopus record for the publication. To access the full text of a record, you can click the Full Text Options to get to the Find It or View at Publisher buttons.

Scopus Title Record

Searching for authors To search for authors, click the Author search tab above the search box. 

Scopus Author Search

Here you can search for authors and documents they have published based on name, keyword, and even ORCID . 

You can also narrow your search by exact matches only or by limiting results to specified subject areas. Each author returned in the results list links to a page that profiles their publications and citations as well as provides measures of their scholarly impact.

Scopus Author Details Page

Searching for affiliations To search for affiliations (i.e., institutions), click the Affiliation search tab above the search box. 

Scopus Affiliation Search

Here, you can search by institution name, such as University of Minnesota.

Results from this search link to affiliation profiles that provide access to documents and authors associated with the respective institution. In addition, these profiles provide some statistics of an affiliation’s scholarly output, including documents by subject area, documents by publication source, and collaborating institutions.

Scopus Affiliation Record

Creating advanced searches Scopus provides the option of creating advanced searches to customize the results that are returned. To do this, click the Advanced search tab above the search box. 

Scopus Advanced Search

In this page, you are provided a text box where you can specify all the parameters of your search using the field codes listed.

Getting full text

When using Library resources, the FindIt link is your connection to accessing the full text of articles if a PDF link is not already visible.

how to download research papers from scopus

This short video will show you how to get to the articles you need for your research paper or other University of Minnesota assignments. Never pay for articles! If we don't have it online, request it and we will get it for you. 

Exporting Results From Scopus

Scopus allows you to export results lists (including all search results, ‘My Lists’ and ‘Saved Lists’), documents and documents references. These can be exported either to a file or a reference management tool (e.g. EndNote, Zotero).

  • Select the document or documents you would like to export .
  • Click the ‘ Export ’ link. A list of file or reference management tools will appear. 
  • If this is the first time you are exporting , select your reference management tool or file type.
  • Once you choose your file type or reference management tool, an export options box will appear.  Choose what citation information you want to export.  You can also save this template as a preference. Then click Export.
  • Your export begins.

Personal account

You can create an Elsevier account for free.   With an Elsevier account you can save a search from any documents results list, or from within your current search history.

  • Run a document search or an advanced search . A document search results page opens.
  • From your document search results, click ‘ Save search’ which appears to the left of your search results. The "Save this search" popup opens.
  • From within the Save this search popup, enter a name for the new Saved search .
  • Click ‘ Save ’. Your search is saved and can be accessed by clicking on the Saved Searches link located above the Search History.

If you are not signed into Scopus, you have the option to add selected documents from your results list to a temporary session-based list.   When you sign out of Scopus, the documents in your temporary list are deleted.  If you are signed into Scopus, you have the option to save documents to a list which may be accessed anytime you are signed into Scopus.  You can rename, edit, delete, add documents to, or export your lists of documents in Scopus account. These lists are available any time when you sign in to Scopus and can be modified or exported according to your research needs.

You can setup and manage alerts in Scopus

how to download research papers from scopus

  • From the Set search alert page or Set Alert pop-up, enter a ‘Name of alert’ .
  • In ‘ E-mail address’ , enter the email address for alert notifications. This field automatically displays the email address entered when you first registered to use Scopus. You can also enter email addresses of colleagues. Separate multiple email addresses with a semicolon, comma, or space, or press ‘ Enter’ on your keyboard. If a colleague unsubscribes from the alert, you will receive an email informing you of the action.
  • From ‘ Frequency’ , select how often you want to receive alert email notices. For weekly alerts you can choose which day of the week you receive the alert, and for monthly alerts you can choose which day you receive the alert. Note: If there are no new documents matching your alert criteria during the time-frame or frequency you choose, you will not receive an alert.
  • Click on "set search alert" to save the alert.
  • Once you have created your Alert, it can be accessed on the Alert page.  On that page you can select ‘ Active’ or ‘ Inactive’ as the status of your alert. You can change this setting on the Alerts page without losing your frequency preferences. Setting an alert to ‘ Inactive’ status does not delete the alert.

Scopus Tutorials : Scopus tutorials provide a visual tour of Scopus and its functions, but are without sound. The tutorials below are also found in the relevant FAQs in the Scopus Support Center.

Scopus Tutorial: How to conduct a basic search (2022 July 12): 3:10 min

Scopus Tutorial: How to use advanced search (2022 July 13): 3:04 min.

Scopus Tutorial: How to Expand Your Search (2022 July 13): 2:32 min.

Scopus Tutorial: How to Create Citation Overview (2022 July 22): 2:48 min

Scopus Tutorial: Understand how author profiles work (2022 July 21): 2:14 min.

Scopus Tutorial: How to save searches and set alerts (2022 July 13): 2:13 min.

Scopus is useful for learning and research. Beyond serving as simply a citation index, however, it is also useful for assessing scholarly impact. As a result, data from Scopus form the foundation for Manifold , one of the University's research impact tracking systems.

What is Manifold? Manifold is a web-accessible interface that generates profiles and reports of research impact and scholarly output for faculty and departments in the University of Minnesota Medical School. Built in response to emerging expectations and needs around faculty scholarship, Manifold harvests publication data from Scopus, including citation counts, to provide metrics of research impact and productivity for Medical School faculty and departments. In addition, Manifold provides an easy mechanism for identifying nominees for the Wall of Scholarship , which showcases research excellence among Medical School faculty. As more needs around assessment emerge at the University, the system continues to be enhanced to meet new demands on the data that Scopus provides on faculty scholarship.

For more information about Manifold, please consult the Manifold Frequently Asked Questions page.

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Scopus Search

Scopus quickly delivers the information you're looking for from over 92m records. Updated daily, Scopus features state-of-the-art search tools and filters to empower research efficiency.

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Increase research efficiency

Having access to comprehensive content and high-quality data is only effective if you can easily find the information you need. Uncovering trends, discovering sources and potential collaborators, and building deeper insights require effective search tools that can identify the right results.

Identify trends for key topics

Scopus’ literature search is built to distill massive amounts of information down to the most relevant documents and information in less time.

With Scopus you can search and filter results in the following ways:

Document search : Search directly from the homepage and use detailed search options to ensure you find the document(s) you want

Author search : Search for a specific author by name or by Open Research and Contributor Identifier ID (ORCID)

Affiliation search : Identify and assess an affiliation’s scholarly output, collaborating institutions and top authors

Advanced search : Narrow the scope of your search using field codes, proximity operators and/or Boolean operators

Refine results : Scopus makes it easy to refine your results list to specific categories of documents

Language interface : The Scopus interface is available in Chinese and Japanese; content is not localized, but you can switch the interface to one of these language options (and switch back to English, the default language) at the bottom of any Scopus page

Quick reference guide

Learn how to easily start your search from the homepage and use all the features in Scopus with this handy Quick Reference Guide.

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Scopus quick reference guide

Learn how Scopus can help your organization achieve its goals.

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Scopus Document Download Manager

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Scopus authenticated users can download PDF files directly from Scopus!

This extension only works for Scopus authenticated users. The Scopus download manager will not do anything for unauthenticated users. Scopus Document Download Manager is a free browser extension enabling download functionality in Scopus, as well as a Quick Document Search function for Scopus authenticated users. To search, authenticated users can simply click on the browser extension icon to display the search form. This extension saves authenticated users the hassle of visiting individual publisher web sites to download documents one by one. Instead, it seamlessly connects to publisher websites to download full text PDFs directly from your browser without needing to configure and maintain a list of entitlements. How do you use this extension in Scopus? 1) From the document search results or document list pages, select one or several documents and click on Download button or 2) From a Scopus abstract record page, click on Download button When successfully downloaded, your PDF document(s) will be saved to your browser Downloads folder. In the event that the extension fails at retrieving the PDF (e.g. you are not entitled to the full text or the download is prevented by the publisher web site) the Document Download Manager will provide a link to the publisher web site so you can easily open the page and try to download the full text manually.

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how to download research papers from scopus

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Expertly curated abstract & citation database

About Scopus

Scopus is the largest abstract and citation database of peer-reviewed literature: scientific journals, books and conference proceedings. Delivering a comprehensive overview of the world's research output in the fields of science, technology, medicine, social sciences, and arts and humanities, Scopus features smart tools to track, analyse and visualise research.

As research becomes increasingly global, interdisciplinary and collaborative, you can make sure that critical research from around the world is not missed when you choose Scopus.

“Speed is very important … I can easily identify what I need to know, read it, digest it and move on to the next one.” James, Research Pathologist, Medical Device R&D, Scopus user
“Scopus is very customer-friendly… You get more information from all different fields. It saves a lot of time.” Chris, Head of R&D, Diagnostic Testing, Scopus user
“Scopus informs every phase of the editorial process. I would not want to do this job without it, and I intend to continue using it throughout my career.” William, Professor of Economics, University of Tennessee

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  • NASI Scopus Young Scientists Awards 2019

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Searching Scopus: Using Scopus

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About Scopus

Basic search, advanced search, author name search, citation searching, creating alerts, exporting items to citation managers, analyzing results, create bibliography.

  • Comparison between Scopus and Web of Science
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Scopus is an abstract and citation database of peer-reviewed literature and web sources with tools to track, analyze, and visualize research. Scopus provides access to a broad portfolio of peer-reviewed content from around the world. 

Scopus includes the records from the MEDLINE and EMBASE databases, among other included sources. Scopus uses four broad subject areas:  Physical Sciences , Health Sciences , Social Sciences, and Life Sciences . 

Scopus allows users to:

  • Search for articles, conference proceedings,trade publications, and book chapters on a topic
  • Find author information, such as H-index, and lists of publications
  • Locate Impact metrics for a journal title using SNIP, SJR, and CiteScore
  • Perform citation searches on known articles
  • Identify promising journals in which to publish
  • Match an organization with its research output
  • Locate potential collaborators or subject experts
  • Manage your impact with your ORCID ID
  • Set Citation Alerts

Search Form

Below is the Scopus search screen. Enter your first search term into the search field. If you have more than one concept to your search, select "Add Search Field" to add additional search fields, or conduct separate searches and combine them later using the "Search" button. 

Scopus does NOT have MeSH terms  or other subject headings on which to search. 

Scopus defaults to searching an article's Title, Abstract and Keywords.  You can change this in Advanced (see the tab to the left for information on Advanced searching).

Scopus Basic Search

Adapted from Rush University Library's  "Scopus User Guide"

On the Advanced search form, you can create a search using field codes, proximity operators, or boolean operators to narrow the scope of the search.

To create an advanced search, Click "Advanced Search" from the main search page

Scopus advanced search form

To search for keywords in an article's title or abstract, type in  TITLE-ABS before your search terms.  Be sure to use parentheses!  For example, this is correct:  (TITLE-ABS( children OR pediatrics))   but this is not correct:  TITLE-ABS children OR pediatrics

When doing a Boolean search, Scopus insists that parentheses be used correctly.  If you get a message about a Syntax Error, check your (( )).

Scopus needs Boolean operators (AND, OR) to be capitalized.  To exclude in Scopus, you must use AND NOT (not just 'NOT').

Scopus is a great place to look for information about a particular author's published works.    You can start your search for information on Scopus's main search page by clicking "Authors."  While Scopus is a compilation of peer-reviewed articles, it is not comprehensive, so keep in mind that you will only see information about the articles that have been indexed into Scopus.

Start exploring search box- authors

Type in the author's last name, and first name if it will be helpful to locate them.  It is often a good idea to put an Affiliation as well.

how to download research papers from scopus

The author's information will appear.  To see all their published work that has been indexed into Scopus, click the box in front of their name and then click "Show documents."

If you are checking on your own citations and notice that you have more than one listing, click "Request to merge authors."

Image showing author's information

If this is your information and there are multiple BOXES for your name, you can merge them by clicking the "Request to merge authors" link and following the steps.

For a visual representation of this author's work, click the box for All, then "View citation information."

  • Scopus Advanced Search Video Tutorial

To find citation counts in Scopus

  • Go to the  Scopus database
  • Search by the document's title
  • In the results list, look in the far-right hand column for the citation count.
  • To see what documents cited the document, click on the citation count.

By registering as a Scopus user, you are able to create search, document, and author alert s to stay up-to-date at your desired frequency. Use these alerts to receive email notices when new documents are loaded on Scopus. From the Alerts page, you can create alerts, view the latest results for an alert, edit alerts, and delete alerts. There is no limit on the number of alerts you can create.

A Search alert is a saved search that you can schedule to run at certain intervals. If any new results are found, you will receive an email with the first 25 results and a link into Scopus to access all new results. You must be logged in to set an alert or work with your saved alerts.

To set a new search alert:

  • From the  D ocument Search page, perform a new search. The Search results page opens.
  • From the search results page, click  Set alert . The Set Alert pop-up appears.
  • Set the frequency and day of week to start alerts.

To set an author alert:

  • From the Author page, perform a new search. The Search results page opens.
  • From the search results page, click an author's name. The author details page opens.
  • From the author details page, click  Get citation alerts . The Set Alert Author Citation Alert pop-up opens.

To set a document alert:

  • From the Document search page, perform a new search. The Search results page opens.
  • From the search results page, click an document's name. The Document details page opens.
  • From the Document details page, click  Set citation alerts . The Set Document Citation Alert pop-up opens.

To export items to SciWheel, EndNote, Zotero, or another citation manager, look in the grey bar (found at the top of your search results) for the words "RIS Export."   Note that you can also email citations (with links) to yourself in this bar.

You can export or email individual citations using the links in this bar, or you can save citations into a List and export/email the entire list at once by using the List function.  See "Saving Items in a List" in the tabs to the left for more information. 

RIS export to citation manager

The drop-down arrow next to "RIS Export" provides options for what information you'd like to export.  We recommend checking of all boxes so that all information is sent.

>Analyze Search Results

Scopus offers several built-in functions for analyzing search results.  You can find these options here:

Analyze Results shown by author

The analysis tools provide a summary view of aspects of the search results, such as counts of publications:

  • By document source (ex. Journal Title)
  • By affiliation (author organization)
  • By document type (ie. journal article, book chapter, etc.)
  • And several other criterion

With Scopus, you can create a bibliography of articles on the fly. 

1. Select the articles in your search set that you would like to include in your bibliography. You can do this by checking off the boxes of the articles you want, or by using the "add to list" feature to just add those articles you want. When you add the articles to the list, your list will open. From there, select all. 

select articles to include and click on create bibliography

2.  Click on the three dots at the top right that indicate "more menu options".  Select the option "Create Bibliography".

select format and citation style

3. Select which format you want (HTML or text) and select the appropriate citation style. Click on "Create Bibliography".

bibliography

  • Next: Comparison between Scopus and Web of Science >>
  • Last Updated: May 14, 2024 12:50 PM
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How can I put my publications into Scopus?

I've got many papers which are not on Scopus, but are picked up by Google Scholar. How do I include all those other papers into Scopus?

Mariano Ramirez's user avatar

2 Answers 2

Scopus uses its own sources for publications in the form of publisher provided content. Their selection procedure is explained here: https://www.elsevier.com/solutions/scopus/content/content-policy-and-selection

There is no procedure to add individual documents to Scopus that I could find on their help pages. You should also be aware that it can take several weeks for a published paper to end up in Scopus. Some publishers (smaller publishers typically or new open-access publishers), conferences, technical reports might never make it to Scopus though.

On a related note, the citation count will probably lag behind Google Scholar.

Pierre de Buyl's user avatar

  • 7 "Some publishers (smaller publishers typically or new open-access publishers) ... never make it to Scopus though." That isn't a correct impression. It's not just smaller publishers or new OA publishers who's journals do not get selected for indexing in Scopus. Hundreds of Elsevier (a large publisher) journals are not even indexed in Scopus, and Scopus is owned and run by Elsevier(RELX Group)! Choice of what gets indexed in Scopus is quite arbitrary. Some say it is a 'quality' filter, but in my opinion the binary of IN or OUT is very harsh on some journals which are left 'OUT' of Scopus. –  rmounce Commented Sep 26, 2018 at 11:17

It sounds like you don't understand what Scopus is. Scopus is a database of quality-curated journals and the articles published in those journals. It isn't meant to be comprehensive, and because it's quality-curated, it doesn't mean that all your papers will automatically end up in the database. Comparatively Google Scholar goes for comprehensiveness. It doesn't have a quality bar, and it'll index literally everything and anything. You should be able to find all your papers in Google Scholar, but not in Scopus.

To get your publications into Scopus, publish in a journal that's indexed by Scopus. It's as simple as that. If you've already published elsewhere, it's too late (unless the journal becomes indexed by Scopus).

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Scopus Tip & Trick: How to export your bibliography from Scopus for use in NIH platforms and tools

Exportscopusauthordetailsintosciencv.png.

how to download research papers from scopus

To learn how this works, follow this tip & trick. It walks you through exporting your Scopus author profile in an RIS format file, importing it into NIH My NCIB tools, using the profile data in the SciENcv platform to create a biosketch, and adding it to your NIH RePORTER profile.

Step 1: Find, check and export your Scopus profile

  • Run an Author search on Scopus using your first name, last name, ORCID iD etc.
  • From the author search results, find and click on your name to open the Author details page

ScopusAuthorDetailsPage_exportingbibliography

This image shows the Scopus author details page and using the documents tab to export your author bibliograph

  • Review your details page (TIP: Refer to this tip & trick for help on checking the accuracy of your profile ) 

NOTE: If you plan to share your profile on NIH RePORTER, be sure to copy or write down the URL of your Scopus author profile page.

  • Go to the Documents tab, which appears just below the author summary box. In this tab, you will find your list of documents indexed on Scopus.
  • Look for and click the Export icon (Note: Depending on how you use Scopus, this might be displayed according to your export preference., i.e. Save to Mendeley , Export all to RIS file, etc. To select a different export method than what is displayed, click on the drop-down arrow).
  • From the pop-up menu, select RIS format for your file format and Citation information only as the information to export
  • Click Export and save the file to use in the desired application or program

ScopusAuthorDetailsPage_step2

how to download research papers from scopus

Step 2: Import your profile into NIH My NCBI My Bibliography

  • Go to the NIH's NCBI and click on “Sign in to NCBI” on the top right corner of the screen.
  • Enter your details and sign in.
  • Once signed in, click on “My NCBI”.
  • Select “Manage My Bibliography”.
  • Click “Upload a file” on the right hand side of the page.
  • Select the RIS file you saved from Scopus.
  • After completing these steps, NCBI will upload your information and, if required, assist you in completing any additional steps, such as providing additional information about publications such as their PMCIDs.

Step 3: Get your profile URL from My NCBI

Follow the instruction which applies to you:

Get a profile URL from My NCBI Collection:

  • Go to the homepage for My NCBI and click on “Public” in My Bibliography collection.
  • Copy the URL from the section “Share your bibliography with this URL”.

Get a profile URL from My NCBI Sketchbook:

  • Go to the homepage for My NCBI and click on “Manage SciENcv” or, if this section is empty, go to “Click here to create a new CV.”
  • Provide the required information (i.e. Name, Format (NIH Biosketch)), and click “Create”.
  • Go to the section “C. Contribution to Science” and click “Edit”.
  • Select “Include link” and then click “Done”.
  • You will see a new link beginning with http://bit.ly/ . This leads to your list of publications as curated on NIH My NCBI. Copy the link so you can reuse it in NIH RePORTER.

Step 4: Add your Scopus and My NCBI profile URLs to your NIH RePORTER profile

  • Go to NIH RePORTER .
  • Search for your name using the query section. Note: You will find your name only if you have been a PI or Project Lead on an awarded grant.
  • Click on your name in the results list.
  • Click “Click here to manage your profile list”.
  • Paste in your Scopus author profile and NCBI My Bibliography links (as explained in steps 1 and 2 above)  
  • Click “Submit profile”.
  • Once finished, you should receive a confirmation email.

This tip & trick is based on the help file: “ How do I export my Scopus data into NIH My Bibliography and SciENcv ?” found on the Scopus Support Center.

Reference management. Clean and simple.

The top list of academic search engines

academic search engines

1. Google Scholar

4. science.gov, 5. semantic scholar, 6. baidu scholar, get the most out of academic search engines, frequently asked questions about academic search engines, related articles.

Academic search engines have become the number one resource to turn to in order to find research papers and other scholarly sources. While classic academic databases like Web of Science and Scopus are locked behind paywalls, Google Scholar and others can be accessed free of charge. In order to help you get your research done fast, we have compiled the top list of free academic search engines.

Google Scholar is the clear number one when it comes to academic search engines. It's the power of Google searches applied to research papers and patents. It not only lets you find research papers for all academic disciplines for free but also often provides links to full-text PDF files.

  • Coverage: approx. 200 million articles
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Search interface of Google Scholar

BASE is hosted at Bielefeld University in Germany. That is also where its name stems from (Bielefeld Academic Search Engine).

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Search interface of Bielefeld Academic Search Engine aka BASE

CORE is an academic search engine dedicated to open-access research papers. For each search result, a link to the full-text PDF or full-text web page is provided.

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Search interface of the CORE academic search engine

Science.gov is a fantastic resource as it bundles and offers free access to search results from more than 15 U.S. federal agencies. There is no need anymore to query all those resources separately!

  • Coverage: approx. 200 million articles and reports
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Search interface of Science.gov

Semantic Scholar is the new kid on the block. Its mission is to provide more relevant and impactful search results using AI-powered algorithms that find hidden connections and links between research topics.

  • Coverage: approx. 40 million articles
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Search interface of Semantic Scholar

Although Baidu Scholar's interface is in Chinese, its index contains research papers in English as well as Chinese.

  • Coverage: no detailed statistics available, approx. 100 million articles
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Search interface of Baidu Scholar

RefSeek searches more than one billion documents from academic and organizational websites. Its clean interface makes it especially easy to use for students and new researchers.

  • Coverage: no detailed statistics available, approx. 1 billion documents
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  • Export formats: not available

Search interface of RefSeek

Consider using a reference manager like Paperpile to save, organize, and cite your references. Paperpile integrates with Google Scholar and many popular databases, so you can save references and PDFs directly to your library using the Paperpile buttons:

how to download research papers from scopus

Google Scholar is an academic search engine, and it is the clear number one when it comes to academic search engines. It's the power of Google searches applied to research papers and patents. It not only let's you find research papers for all academic disciplines for free, but also often provides links to full text PDF file.

Semantic Scholar is a free, AI-powered research tool for scientific literature developed at the Allen Institute for AI. Sematic Scholar was publicly released in 2015 and uses advances in natural language processing to provide summaries for scholarly papers.

BASE , as its name suggest is an academic search engine. It is hosted at Bielefeld University in Germany and that's where it name stems from (Bielefeld Academic Search Engine).

CORE is an academic search engine dedicated to open access research papers. For each search result a link to the full text PDF or full text web page is provided.

Science.gov is a fantastic resource as it bundles and offers free access to search results from more than 15 U.S. federal agencies. There is no need any more to query all those resources separately!

how to download research papers from scopus

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  • URL: https://libguides.depaul.edu/c.php?g=1403732

This paper is in the following e-collection/theme issue:

Published on 11.7.2024 in Vol 26 (2024)

Comparison of the Response to an Electronic Versus a Traditional Informed Consent Procedure in Terms of Clinical Patient Characteristics: Observational Study

Authors of this article:

Author Orcid Image

Original Paper

  • Anna G M Zondag 1 , MSc   ; 
  • Marieke J Hollestelle 2 , PhD   ; 
  • Rieke van der Graaf 2 , PhD   ; 
  • Hendrik M Nathoe 3 , MD, PhD   ; 
  • Wouter W van Solinge 1 , PhD   ; 
  • Michiel L Bots 2 , MD, PhD   ; 
  • Robin W M Vernooij 2, 4 , PhD   ; 
  • Saskia Haitjema 1 , MD, PhD   ; 
  • UCC-CVRM study group 5

1 Central Diagnostic Laboratory, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands

2 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands

3 Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands

4 Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht, Netherlands

5 See Acknowledgements

Corresponding Author:

Anna G M Zondag, MSc

Central Diagnostic Laboratory

University Medical Center Utrecht

Utrecht University

Heidelberglaan 100

Utrecht, 3584 CX

Netherlands

Phone: 31 631117922

Email: [email protected]

Background: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.

Objective: We evaluated the eIC pilot by comparing the response to the eIC with the former traditional paper-based informed consent (IC). We assessed whether the use of eIC resulted in a different study population by comparing the clinical patient characteristics between the response categories of the eIC and former face-to-face IC procedure.

Methods: All patients with increased cardiovascular risk visiting the University Medical Center Utrecht, the Netherlands, were eligible for the learning health care system. From November 2021 to August 2022, an eIC was piloted at the cardiology outpatient clinic. Prior to the pilot, a traditional face-to-face paper-based IC approach was used. Responses (ie, consent, no consent, or nonresponse) were assessed and compared between the eIC and face-to-face IC cohorts. Clinical characteristics of consenting and nonresponding patients were compared between and within the eIC and the face-to-face cohorts using multivariable regression analyses.

Results: A total of 2254 patients were included in the face-to-face IC cohort and 885 patients in the eIC cohort. Full consent was more often obtained in the eIC than in the face-to-face cohort (415/885, 46.9% vs 876/2254, 38.9%, respectively). Apart from lower mean hemoglobin in the full consent group of the eIC cohort (8.5 vs 8.8; P =.0021), the characteristics of the full consenting patients did not differ between the eIC and face-to-face IC cohorts. In the eIC cohort, only age differed between the full consent and the nonresponse group (median 60 vs 56; P =.0002, respectively), whereas in the face-to-face IC cohort, the full consent group seemed healthier (ie, higher hemoglobin, lower glycated hemoglobin [HbA 1c ], lower C-reactive protein levels) than the nonresponse group.

Conclusions: More patients provided full consent using an eIC. In addition, the study population remained broadly similar. The face-to-face IC approach seemed to result in a healthier study population (ie, full consenting patients) than the patients without IC, while in the eIC cohort, the characteristics between consent groups were comparable. Thus, an eIC may lead to a better representation of the target population, increasing the generalizability of results.

Introduction

The use of electronic informed consent (eIC) procedures in clinical research is increasing due to several benefits, including increased enrollment and improved efficiency, by reducing the need for on-site research staff and the associated paperwork [ 1 - 3 ]. eICs have the potential to improve the patient experience (eg, patient understanding and confidence) of the informed consent (IC) process, in part because of the ability to include digital multimedia [ 4 , 5 ]. Alternatively, concerns were raised about whether eIC forms are easily accessible to an elderly population and those with limited digital literacy [ 6 ], making it more difficult to assess whether the patient has fully understood the IC form, one of the requirements for a valid IC [ 7 ]. Standardized best practices for eIC procedures are still lacking [ 5 , 8 ].

In 2014, the University Medical Center (UMC) Utrecht in the Netherlands initiated the Utrecht Cardiovascular Cohort-CardioVascular Risk Management (UCC-CVRM) as a learning health care system (LHS). The UCC-CVRM LHS aims to improve uniform assessment and registration of cardiovascular risk indicators, based on Dutch national guidelines, in electronic health records (EHRs) for all patients referred to the UMC Utrecht for cardiovascular evaluation [ 9 ]. In an LHS, care and research are integrated in such a way that health care activities are continuously analyzed and the knowledge gained from these analyses is used to improve care by changing health care practices [ 10 ]. In the case of UCC-CVRM LHS, a traditional face-to-face IC procedure was used for blood sample storage in a biobank and the reuse of routine care data for scientific research purposes including linkage of data from EHRs to national registries [ 9 ]. In 2020, during the COVID-19 pandemic, the UCC-CVRM steering committee evaluated the study including the IC procedure [ 11 , 12 ]. In short, less than half of the patients who were invited to participate, 41.5% (2378/5730), provided written IC [ 12 ]. Next, patients who did consent differed in clinical characteristics from those nonconsenting or nonresponding, clearly leading to a selection of patients not representable for all eligible patients. For example, consenting patients had a lower cardiovascular disease burden than nonconsenting patients [ 11 , 12 ]. In addition, structured registration of cardiovascular risk management (CVRM) indicators in the EHR was worse compared with consenting patients. This selection is detrimental to an LHS, as the population included in the LHS may be less representative of the target population as a whole [ 11 , 12 ]. Finally, eligible patients were not invited, mainly because of the time-consuming and unsustainable IC procedure due to changes in personnel and changes in priorities during peak periods (eg, the COVID-19 pandemic) [ 13 ].

Therefore, the UCC-CVRM steering committee decided to alter the approach. Identification of eligible patients for the LHS was to be automated and CVRM data, to be assessed regularly in patients at higher cardiovascular risk, were extracted from structured fields in the EHR. To still enable the linkage of this patient information to data from national registries, general practitioners (GPs), and other hospitals, an eIC procedure was piloted. This study aims to evaluate the eIC procedure by studying the response to the IC form. In addition, we aim to assess whether the change in the IC procedure leads to a different study population by investigating potential differences in clinical characteristics between the response categories of the eIC compared with the former face-to-face IC procedure.

We used the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement as a reporting guideline for this study.

Study Setting

Patients visiting the UMC Utrecht for the first time for the evaluation of cardiovascular disease or risk factors were eligible for inclusion in the UCC-CVRM LHS. The full rationale of UCC-CVRM has been described elsewhere [ 9 ]. The eIC pilot was conducted between November 2021 and August 2022. During this period, all patients (18 years and older) visiting the cardiology outpatient clinic for first-time evaluation automatically received an email. This email notified these patients about UCC-CVRM and the associated eIC form that was available for completion in the UMC Utrecht patient portal. The IC procedures of the face-to-face IC and eIC are illustrated in Figure 1 . The full details eIC form presented to the patients in the patient portal are included in Multimedia Appendix 1 .

In both the face-to-face IC and the eIC forms, IC was asked for linkage with national registries, GPs, and other hospitals through the following two statements: (1) I consent to future requests to link with various international or national registries, such as the Central Bureau of Statistics (also known as Statistics Netherlands) where all causes of death are registered, the Dutch Cancer Registration (NKR), where all people with cancer are registered, the National Basic Registration of Hospital Care (LBZ), where all hospital admissions are registered, the Foundation for Pharmaceutical Statistics (SFK), where all people who use medicines are registered, and other regional and national registries. (2) I consent to the retrieval of my medical information from my GP, my pharmacy, and any other hospitals where I have been treated in the past.

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Data Collection

We collected data from all patients aged 18 years or older referred to a cardiology outpatient clinic. We used the Utrecht Patient Oriented Database to collect data from the patients who participated in the eIC pilot, referred to as the “eIC cohort.” The Utrecht Patient Oriented Database comprises data on, among others, patient characteristics and laboratory tests for all patients treated at the UMC Utrecht since 2004 [ 14 ]. We collected routine care data related to the patient’s demographics and cardiovascular risk, namely blood pressure, BMI, and laboratory measurements (serum lipids, glycated hemoglobin [HbA 1c ], hemoglobin, and renal function). These data were also collected for the cardiology patients who were invited during the period in which a face-to-face IC procedure was in place, referred to as the “face-to-face IC cohort.” From the face-to-face IC cohort, only patients invited up until December 31, 2019, were included because the COVID-19 pandemic significantly hampered the face-to-face IC procedure.

All measurements were extracted from structured fields in the EHR. Blood pressure values were extracted from the EHR ±7 days from the date of the visit at the cardiology outpatient clinic. For other measurements, the closest value, within ±21 days of the visit date, was extracted. If no measurements were found within these cutoffs, the measurement was considered missing. An overview of missingness per variable is added as Multimedia Appendix 2 . Age was calculated by subtracting the date of the visit from the patient’s date of birth. The estimated glomerular filtration rate was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation and used as a measure of renal function [ 15 ].

Data Analyses

We presented the yield for both the eIC and face-to-face IC cohort as counts and the percentages of patients who, (1) consented to the linkage of their data with their GP, pharmacy, and other hospitals, and linkage with national registries (ie, “full consent”); (2) did not consent for the linkage of their data with their GP, pharmacy, and other hospitals, nor to the linkage with national registries (ie, “nonconsent”); (3) consented to only 1 of the 2; and (4) the percentage of patients who did not respond at all or provided an answer for only 1 of the 2 statements (ie, “nonresponse”). Due to the limited number of observations in some IC response groups (n<25), especially in the eIC cohort, other than the full consent (n=1291) and nonresponse (n=1477) group, further analyses were restricted to the full consent and nonresponse group only.

To assess differences in patient groups, characteristics of the patients with full consent were stratified by cohort (ie, eIC cohort vs face-to-face IC cohort). As a supplement, we also explored the characteristics of the nonresponders by cohort. Finally, we assessed the differences in patient characteristics between the response categories within each cohort (ie, full consent versus nonresponse).

Clinical characteristics were presented as means with corresponding SDs, medians with corresponding interquartile ranges, or counts and percentages, as appropriate. To quantify differences in characteristics between cohorts, or response categories within cohorts, we performed multivariable linear regression analyses, adjusted for age, categorized into 4 categories with an approximately equal number of observations (18 to 47, 48 to 60, 61 to 70, and 71 to 95 years old), and sex. The assumptions of linear regression (eg, approximate normal distribution of the error terms, homoscedasticity of errors) were assessed. Where needed, we used the Box-Cox method to estimate the most appropriate transformation of the dependent variable to stabilize the variance and improve the accuracy of our estimations [ 16 ]. Similarly, multivariable linear regression was used to assess the difference in age (as a continuous variable) between groups, adjusted for sex. Multivariable logistic regression was used to assess the difference in sex between the groups (ie, between the 2 cohorts and between the response categories within each cohort), adjusted for age (categorized into 4 categories with an approximately equal number of observations). As a sensitivity analysis, we repeated the adjusted regression analyses with age as a continuous variable, to assess whether the categorization led to different results.

We used the Bonferroni correction to reduce the risk of a type I error resulting from the multiple tests [ 17 ]. Thus, the α that we considered as cutoff, .05, was divided by the number of analyses (N=13) performed per comparison. Therefore, a P value ≤.0038 was considered statistically significant.

All statistical analyses were performed using R software (version 4.0.5; The R Foundation) [ 18 ].

Ethical Considerations

We obtained an additional ethical waiver (number 19/641) from the Research Ethics Committee Utrecht to examine the characteristics of patients in all IC response categories. Patients who objected to the use of their clinical data for research purposes via the UMC Utrecht opt-out procedure were excluded from this study. Data were pseudonymized and the patients did not receive any compensation for their participation in this study.

Yield of the IC Procedure

In total, 3139 patients participated in this study, of whom 885 (28.2%) participated in the eIC pilot cohort and 2254 (71.8%) in the face-to-face IC cohort ( Multimedia Appendix 3 ). Of all patients from the eIC cohort, 49.9% (442/885) completed the eIC form, 50.1% (443/885) did not respond. Of all patients who completed the eIC form, we obtained full consent for linkage with GPs, hospitals, and national registries from 93.9% (415/442) of the patients. In the face-to-face IC cohort, 54.1% (1220/2254) of all patients completed the IC form, and 45.9% (1034/2254) patients did not respond. The percentage of responding patients with full consent was higher in the eIC cohort as compared with the face-to-face IC cohort (415/442, 93.9% vs 876/1220, 71.8%, respectively).

Differences in Characteristics Between the eIC and Face-to-Face Cohorts

Overall, fully consenting patients had similar patient characteristics ( Table 1 ). Adjusted for sex and age, the eIC cohort had lower hemoglobin levels and higher HbA 1c levels than the face-to-face IC cohort, reaching the multiple testing threshold for statistical significance for hemoglobin ( P =.0021).

Similarly, we compared the (clinical) characteristics of the nonresponding patients between cohorts, shown in Multimedia Appendix 4 . Adjusted for sex, the nonresponders of the eIC cohort were significantly younger and had, adjusted for age and sex, lower c-reactive protein values than the nonresponders of the face-to-face cohort. No other differences were observed.

VariableFull consent value

eIC (n=415)F2F IC (n=876)
Age (years), median (IQR)60.0 (48.0-70.0)61.0 (50.0-69.0).2529

Male237 (57.1)476 (54.3)

Female178 (42.9)400 (45.7).3239
BMI (kg/m ), mean (SD)26.6 (5.2)26.7 (5.7).8981
SAP (mm Hg), mean (SD)132.1 (19.4)137.6 (19.6).0586
Hemoglobin (mmol/L), mean (SD)8.5 (1.4)8.8 (0.9).0021
HbA (mmol/mol), median (IQR)37.5 (34.0-44.0)37.0 (34.0-40.0).0454
Cholesterol (mmol/L), mean (SD)4.8 (1.2)5.1 (1.3).1266
HDL -cholesterol (mmol/L), mean (SD)1.3 (0.4)1.4 (0.4).0676
LDL -cholesterol (mmol/L), mean (SD)2.7 (1.1)2.9 (1.1).1086
Triglycerides (mmol/L), median (IQR)1.7 (1.1-2.6)1.6 (1.0-2.1).3023
CRP (mg/L), median (IQR)2.0 (0.5-10.0)2.6 (1.1-8.5).6666
Creatinine (µmol/L), median (IQR)76.0 (64.2-94.0)74.0 (64.0-88.0).7760
eGFR CKD-EPI (mL/min/1.73 m ), mean (SD)83.3 (23.1)84.5 (22.3).7068

a eIC: electronic informed consent.

b F2F IC: face-to-face informed consent.

c Reference group.

d SAP: systolic arterial blood pressure.

e HbA 1c : glycated hemoglobin.

f HDL: high-density lipoprotein.

g LDL: low-density lipoprotein.

h CRP: c-reactive protein.

i eGFR CKD-EPI: estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.

Differences in Characteristics Between Response Categories

Within each cohort, we assessed whether there were differences in characteristics between the response categories (ie, full consent vs nonresponse). In the eIC cohort, the nonresponse group was significantly younger than the full consent group ( Table 2 ). Other than that, the clinical characteristics of the full consent group were similar to those of the nonresponse group.

More differences were found between the response categories of the face-to-face IC cohort. Adjusted for age and sex, patients in the full consent group had higher hemoglobin, but lower HbA 1c and c-reactive protein values than the nonresponse group ( Table 3 ).

VariableFull consent (n=415)Nonresponse (n=443) value
Age (years), median (IQR)60.0 (48.0-70.0)56.0 (28.0-72.0).0002

Male237 (57.1)222 (50.1)

Female178 (42.9)221 (49.9).0420
BMI (kg/m ), mean (SD)26.6 (5.2)26.0 (4.9).3673
SAP (mm Hg), mean (SD)132.1 (19.4)130.4 (19.6).4168
Hemoglobin (mmol/L), mean (SD)8.5 (1.4)8.4 (1.3).2397
HbA (mmol/mol), median (IQR)37.5 (34.0-44.0)37.5 (34.0-40.2).1940
Cholesterol (mmol/L), mean (SD)4.8 (1.2)4.6 (1.5).2852
HDL -cholesterol (mmol/L), mean (SD)1.3 (0.4)1.2 (0.5).3371
LDL -cholesterol (mmol/L), mean (SD)2.7 (1.1)2.6 (0.9).9304
Triglycerides (mmol/L), median (IQR)1.7 (1.1-2.6)1.4 (1.1-2.0).4167
CRP (mg/L), median (IQR)2.0 (0.5-10.0)3.0 (0.5-12.0).5922
Creatinine (µmol/L), median (IQR)76.0 (64.2-94.0)79.0 (64.0-100.5).0897
eGFR CKD-EPI (mL/min/1.73 m ), mean (SD)83.3 (23.1)82.0 (30.7).1103

a Reference group.

b SAP: systolic arterial blood pressure.

c HbA 1c : glycated hemoglobin.

d HDL: high-density lipoprotein.

e LDL: low-density lipoprotein.

f CRP: c-reactive protein.

g eGFR CKD-EPI: estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration equation.

VariableFull consent (n=876)Nonresponse (n=1034) value
Age, median (IQR)61.0 (50.0-69.0)61.0 (48.0-71.0).9461

Male476 (54.3)552 (53.4)

Female400 (45.7)482 (46.6).7859
BMI (kg/m ), mean (SD)26.7 (5.7)26.2 (5.5).1063
SAP (mm Hg), mean (SD)137.6 (19.6)136.3 (22.0).1093
Hemoglobin (mmol/L), mean (SD)8.8 (0.9)8.3 (1.2)<.0001
HbA (mmol/mol), median (IQR)37.0 (34.0-40.0)38.0 (34.0-42.0).0001
Cholesterol (mmol/L), mean (SD)5.1 (1.3)5.0 (1.4).4493
HDL -cholesterol (mmol/L), mean (SD)1.4 (0.4)1.3 (0.4).0898
LDL -cholesterol (mmol/L), mean (SD)2.9 (1.1)2.9 (1.1).2754
Triglycerides (mmol/L), median (IQR)1.6 (1.0-2.1)1.6 (1.0-2.4).0435
CRP (mg/L), median (IQR)2.6 (1.1-8.5)8.1 (2.0-38.2)<.0001
Creatinine (µmol/L), median (IQR)74.0 (64.0-88.0)75.0 (63.0-92.0).4361
eGFR CKD-EPI (mL/min/1.73 m ), mean (SD)84.5 (22.3)81.3 (29.0).0946

Sensitivity Analysis

We repeated the regression analyses adjusted for sex and age. In these regression analyses, age was maintained continuous instead of categorized, to assess whether the categorization of age led to different results. The results were similar ( Multimedia Appendix 5 ).

Principal Results

We showed that by using an eIC in an LHS, patients more often provided full consent to link their data to national registries, GPs, and other hospitals compared with a face-to-face IC procedure. The clinical characteristics of patients with full consent remained largely similar after changing the IC procedure to an eIC. Except for age, we did not find any differences between the response categories of the eIC cohort, whereas in the face-to-face cohort, several differences were found. These differences potentially suggest a higher (cardiovascular) disease burden in the nonresponse group compared with the full consent group, indicative of a potentially more pronounced selection in the face-to-face approach.

A possible explanation for the differences in characteristics between the response categories in the face-to-face cohort is that patients may have been too ill or frail to attend the physical appointment with the research nurse to discuss and sign the IC form, resulting in nonresponse. The inability to attend the appointment was probably less of an issue in the eIC cohort, as patients were able to access the eIC form remotely. The finding suggests that the use of eIC results in a study population (ie, those who give full consent) that is more representative of the full target population. Our findings agree with a previous study showing that providing computer-based clinical study information leads to more willingness to participate [ 19 ], as the increased willingness to participate is consistent with the higher full consent rates found in the eIC group compared with the face-to-face IC group in our study.

Frequently Mentioned Challenges of eICs in the Literature

Concerns have been raised about whether consent given via an eIC is truly an “informed” consent [ 8 ]. According to the principles of the Declaration of Helsinki [ 7 ], potential participants must be adequately informed about various aspects of the study, such as its purpose, sources of funding, the anticipated benefits and potential risks, and the right to refuse or withdraw consent to participate without giving a reason [ 7 ]. According to previous research, comprehension assessment is more challenging when an eIC procedure is used as there is no direct interaction between the potential participant and researcher [ 6 ]. As a result, patients might provide consent without fully understanding what they are consenting to, or, conversely, patients may be less likely to consent because of the lack of personal interaction with the researcher or clinician, especially those who were already doubtful about participating in the first place. However, our findings indicate that the latter might not have been the case in our pilot study, as we observed a higher percentage of patients with full consent in the eIC cohort compared with the face-to-face IC cohort.

Another frequently mentioned concern is that studies using an eIC procedure could become inaccessible to patients who lack the digital literacy needed to access and understand the eIC form [ 6 ]. In 2021, the Netherlands had the highest percentage (ie, 79%) of 17- to 74-year-olds with at least basic digital skills in Europe [ 20 ]. Therefore, incomprehension of the eIC due to limited digital literacy may appear less of an issue in our study. However, the percentage of persons with basic digital skills varied considerably by age, with older people being less literate [ 20 ]. A sensitivity analysis showed that the age distribution of responding patients was similar between the eIC and the face-to-face approach ( Multimedia Appendix 6 ), indicating that the eIC was not less accessible than the face-to-face IC for certain age groups. However, accessibility may be an issue for geriatric patients, who are generally older than cardiology patients and often have geriatric syndromes that sometimes affect comprehension and literacy [ 21 ]. These syndromes generally make it difficult to obtain IC from the elderly [ 21 ]. eIC could, therefore, also be seen as an opportunity. Unlike paper-based ICs, multiple formats can be used to inform the patient about the purpose of the eIC and to provide technical support, for example, by using instructional videos or audio. The use of multiple formats in IC forms for the elderly has been recommended by, among others, Barron et al [ 22 ]. Furthermore, UCC-CVRM’s eIC form is available in UMC Utrecht’s long-existing patient portal. In the portal, patients have the opportunity to, among others, ask questions to their clinician via an e-consult, which can be used if parts of the eIC are unclear [ 23 ]. Another possibility would be a hybrid format, allowing patients who prefer correspondence by regular mail to respond using a paper-based IC form. However, it is questionable whether this would be helpful and it would negate the positive aspects of the eIC highlighted in this study (eg, less pronounced selection).

Legislation and Regulation Regarding eIC

Since July 2022, eICs have been permitted in the Netherlands when certain conditions are met [ 24 ]. A total of 6 conditions are described in the guideline written by the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek) and the Dutch Association of Medical Research Ethics Committees (Nederlandse Vereniging voor Medisch-Ethische toetsingscommissies) [ 25 ]. The most important conditions are (1) eIC must be appropriate for the study, meaning that the study is associated with low potential risk and burden for the patient, (2) the eIC process must be sufficiently reliable and confidential, guaranteed by an electronic system that is compliant to the Dutch General Data Protection Regulation (UAVG in Dutch) and ensures the validity of the electronic signatures, and (3) the eIC procedure must be described in the study protocol [ 24 , 25 ]. The implementation of an eIC seems appropriate in the case of the UCC-CVRM, as no potential risk or burden for the patient is involved. Furthermore, in the eIC of the UCC-CVRM, data security, identity verification, and the validity of the electronic signature are ensured by the Dutch digital ID, an identification method for accessing web-based services [ 26 ]. Regarding the third condition, an amendment to the UCC-CVRM approach, including the eIC, was submitted and approved by the Research Ethics Committee.

Clinical Implications

Based on the results of our study, the use of eIC to obtain IC might be a sustainable and adequate way to enable researchers to link with national registries, GPs, and other hospitals. The use of the eIC seemed to have resulted in a population with consent that is more similar to the target population compared with the face-to-face IC, which is of great importance in an LHS. Results from the LHS would be more generalizable to the target population, namely to all patients at higher cardiovascular risk. Yet, one may argue whether ≈50% response to both the electronic and face-to-face IC for an LHS approach is sufficient. In addition, it should be noted that the extractability of CVRM indicators from structured fields in the EHR was much lower in the eIC cohort compared with the face-to-face IC cohort. Groenhof et al [ 13 ] showed that the former, protocolized, face-to-face UCC-CVRM approach led to more systematic registration of the cardiovascular risk profile in the EHR, which had a positive effect on CVRM guideline adherence in consenting patients, compared with the situation before UCC-CVRM was introduced [ 13 ]. The substantial missingness in the eIC cohort of our study may suggest that these improvements are at risk when the approach is automated, as deviations from the initial protocol are made, potentially leading to suboptimal CVRM in clinical care.

Exploring the views and experiences of patients could help to further improve the eIC form. Therefore, we recommend further qualitative research into the accessibility and understandability of eICs used for similar purposes and in similar settings as the UCC-CVRM LHS from a patient’s perspective.

Strengths and Limitations

To the best of our knowledge, we are among the first to investigate the differences in clinical patient characteristics between response categories of an eIC compared with those of a traditional face-to-face IC, specifically in the context of a cardiovascular LHS in a large sample of patients. Our uniqueness, however, limits the ability to compare our findings to the literature, as most research on eIC has focused on user perspectives, experiences, and the ethical considerations of eICs. For example, Chen et al [ 5 ] showed that in most included studies, participants had a better understanding of the information when using an eIC compared with a traditional paper-based face-to-face IC, while others found no difference [ 5 ]. Nevertheless, they [ 5 ] and others [ 2 , 6 , 27 ] indicated that face-to-face interaction should remain part of the IC process, especially for more complex and higher-risk studies. However, as the UCC-CVRM LHS is not a complex or high-risk study, the face-to-face interaction may be less necessary. Furthermore, the nonresponders in the eIC cohort may not be fully comparable to the nonresponders in the face-to-face IC cohort because, in the eIC cohort, patients received the eIC after their appointment at the cardiology outpatient clinic, whereas in the face-to-face IC cohort, cardiology patients were identified as eligible and received information about the UCC-CVRM LHS prior to their appointment. This means that patients who, for example, canceled their appointment at the last minute would still be included in the face-to-face cohort as nonresponders. It may be that patients who did not attend their appointment at all had different characteristics to those who attended but did not respond to the eIC, potentially affecting the validity of the comparisons made. Finally, the eIC form was piloted in the patient population of the cardiology outpatient clinic only. Although our results indicated that there were only minor differences (ie, hemoglobin) between patients providing full consent using the eIC compared with the face-to-face IC, it remains to be seen whether this would still be the case after implementation of the eIC in other clinical departments.

Conclusions

To conclude, our findings suggest that using an eIC may lead to a better representation of the target population by consenting patients. This increases the generalizability of results from studies using the data collected within the LHS from consenting patients.

Acknowledgments

The Utrecht Cardiovascular Cohort-Cardiovascular Risk Management (UCC-CVRM) is primarily financed by the University Medical Center (UMC) Utrecht (contact information of UCC-CVRM is [email protected]). AGMZ was supported by a grant from the European Union’s Horizon 2020 research and innovation program (grant agreement number 101017331; ODIN). MJH and RvdG were supported by the ZonMw, ETHMIRE project (grant agreement number 91217027). The funding sources were not involved in the design of the study, the analysis and interpretation of the data, the writing of the manuscript, and the decision to submit the manuscript for publication. Members of the UCC-CVRM study group were the following: GJ de Borst, Department of Vascular Surgery; ML Bots (chair), Julius Center for Health Sciences and Primary Care; M Hollander, Julius Center for Health Sciences and Primary Care; MH Emmelot, Department of Geriatrics; PA de Jong, Department of Radiology; AT Lely, Department of Obstetrics/Gynecology; HM Nathoe, Department of Cardiology; IE Hoefer, Central Diagnostic Laboratory; NP van der Kaaij, Department of Cardiothoracic Surgery; YM Ruigrok, Department of Neurology; and MC Verhaar, Department of Nephrology and Hypertension, FLJ Visseren, Department of Vascular Medicine, University Medical Center Utrecht and Utrecht University.

Authors' Contributions

AGMZ, HMN, WWvS, MLB, SH, and RWMV contributed to the conceptualization of the project. AGMZ, RWMV, SH, WWvS, and MLB contributed to the methodology of the project. AGMZ analyzed the data and drafted the manuscript. AGMZ, MJH, RvdG, HMN, WWvS, MLB, SH, and RWMV contributed substantially to the interpretation of the data. The final manuscript was critically reviewed and edited by all authors. Approval of the final manuscript was obtained by all authors.

Conflicts of Interest

None declared.

The electronic informed consent form as presented in the patient portal of the UMC (University Medical Center) Utrecht (translated from Dutch to English).

Missingness per variable in count and percentage, by cohort and informed consent response strata.

Yield (ie, response to the informed consent invitation), by type of informed consent. eIC: electronic informed consent; GP: general practitioner.

Differences between patients who did not respond, by cohort, adjusted for age and sex.

Results of the sensitivity analysis in which age is treated as a continuous variable instead of categorical variable.

Age distribution of patients who completed the informed consent form, stratified by cohort.

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Abbreviations

cardiovascular risk management
electronic health record
electronic informed consent
general practitioner
glycated hemoglobin
informed consent
learning health care system
Strengthening the Reporting of Observational Studies in Epidemiology
Utrecht Cardiovascular Cohort-Cardiovascular Risk Management
University Medical Center

Edited by A Mavragani; submitted 29.11.23; peer-reviewed by CMJ Wong, H Kondylakis; comments to author 28.02.24; revised version received 15.04.24; accepted 10.05.24; published 11.07.24.

©Anna G M Zondag, Marieke J Hollestelle, Rieke van der Graaf, Hendrik M Nathoe, Wouter W van Solinge, Michiel L Bots, Robin W M Vernooij, Saskia Haitjema, UCC-CVRM study group. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 11.07.2024.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

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    To export documents: From the document results page, select the documents you would like to export. Select 'Export'. From the export drop-down menu, choose a file type, reference manager, or platform. Tick the desired boxes to select the information you want to export. Note: tick 'Save as preference' to save the selected export parameters.

  5. Home

    Scopus allows you to export results lists (including all search results, 'My Lists' and 'Saved Lists'), documents and documents references. These can be exported either to a file or a reference management tool (e.g. EndNote, Zotero).. Select the document or documents you would like to export.; Click the 'Export' link.A list of file or reference management tools will appear.

  6. New Document Download Manager feature on Scopus

    We recently launched a new Document Download Manager feature compatible with Google Chrome, the browser of choice for the majority of Scopus users. The Document Download Manager allows you to select one or more abstract and then automatically download the PDF full-text version(s), from publisher web sites.

  7. Scopus search

    Scopus' literature search is built to distill massive amounts of information down to the most relevant documents and information in less time. With Scopus you can search and filter results in the following ways: . Document search: Search directly from the homepage and use detailed search options to ensure you find the document (s) you want.

  8. Document Download Manager

    on Fri, 12/08/2017 - 22:43. We recently launched a new Document Download Manager feature compatible with Google Chrome, the browser of choice for the majority of Scopus users. The Document Download Manager allows you to select one or more abstract and then automatically download the PDF full-text version (s), from publisher web sites.

  9. What's new on Scopus: Introducing the new Document Download Manager

    This week brought several updates and enhancements to Scopus. Continue reading for an overview of the changes to Document Download Manager, Advanced Search, CiteScore, ORCID Document Search and the Author Details Pages. Document Download Manager - Google Chrome Extension

  10. How to Download and Manage Scopus Search Results: A Step-by-Step

    publish https://www.fiverr.com/s/3mVeYa 👋 Welcome to a #Scopus video tutorial on downloading search results.🔍 To begin this process, we have already run a ...

  11. How to download and export your search results with full text on Scopus

    Scopus is used to provide the abstract only. But if we download the "Scopus document download manager" into the Chrome extension, we can access the full-text...

  12. Scopus Document Download Manager

    The Scopus download manager will not do anything for unauthenticated users. Scopus Document Download Manager is a free browser extension enabling download functionality in Scopus, as well as a Quick Document Search function for Scopus authenticated users. ... Fast, one-click access to millions of research papers. Science Research Assistant. 4.8 ...

  13. Scopus

    Your brilliance, connected. Scopus uniquely combines a comprehensive, expertly curated abstract and citation database with enriched data and linked scholarly literature across a wide variety of disciplines. Scopus quickly finds relevant and authoritative research, identifies experts and provides access to reliable data, metrics and analytical ...

  14. Scopus

    About Scopus. Scopus is the largest abstract and citation database of peer-reviewed literature: scientific journals, books and conference proceedings. Delivering a comprehensive overview of the world's research output in the fields of science, technology, medicine, social sciences, and arts and humanities, Scopus features smart tools to track ...

  15. Using Scopus

    Scopus is an abstract and citation database of peer-reviewed literature and web sources with tools to track, analyze, and visualize research. Scopus provides access to a broad portfolio of peer-reviewed content from around the world. Scopus includes the records from the MEDLINE and EMBASE databases, among other included sources. Scopus uses four broad subject areas: Physical Sciences, Health ...

  16. Is there a simple way to bulk download a large number of papers from a

    [Scientific PDF download] RESP: Research Papers Search claims to search and download scientific papers. Yet to try it out. Articledownloader is worth exploring; PyPaperBot is well used for downloading scientific articles from DOI or academic database. I'm busy with a fork of Automated Search Helper. A research project by Lech Madeyski team at ...

  17. Scopus tutorials

    How affiliation profiles work in Scopus. Tutorial text only Search for an affiliation by name. Tutorial text only Search for affiliations by topic. Tutorial text only View an institution's research output. Tutorial text only

  18. How can I put my publications into Scopus?

    You should be able to find all your papers in Google Scholar, but not in Scopus. To get your publications into Scopus, publish in a journal that's indexed by Scopus. It's as simple as that. If you've already published elsewhere, it's too late (unless the journal becomes indexed by Scopus). Share.

  19. Scopus Tip & Trick: How to export your bibliography from Scopus for use

    Scopus uses a powerful algorithm to match researchers' papers to correct author profile(s). The algorithm analyzes deep data such as publishing history, author affiliation and co-citation behavior, to create robust public facing profiles on Scopus, displayed as the Author details page. From this page you can review your profile and request corrections, integrate with ORCID and analyze your ...

  20. The best academic search engines [Update 2024]

    Academic search engines have become the number one resource to turn to in order to find research papers and other scholarly sources. While classic academic databases like Web of Science and Scopus are locked behind paywalls, Google Scholar and others can be accessed free of charge. In order to help you get your research done fast, we have compiled the top list of free academic search engines.

  21. Faculty Research Guide: Where do I publish my research?

    Source Normalized Impact per Paper (SNIP) CiteScore. A family of eight indicators that offer complementary views to analyze the publication influence of serial titles of interest. Derived from the Scopus database, CiteScore metrics offer a more transparent, current, comprehensive and accurate indication of a serial's impact.

  22. Journal of Medical Internet Research

    Background: Electronic informed consent (eIC) is increasingly used in clinical research due to several benefits including increased enrollment and improved efficiency. Within a learning health care system, a pilot was conducted with an eIC for linking data from electronic health records with national registries, general practitioners, and other hospitals.

  23. How do I search in Scopus?

    Added to Scopus in the last no. days: Limit your search to documents that have been added to Scopus in the last 7, 14, or 30 days. Document type. Use the document type list to limit your search to a specific type of document, such as reviews or conference papers. Open Access. Scopus has a number of documents labeled as Open Access (OA).

  24. How to download and export your search results tutorial

    To post social content, you must have a display name. The page will refresh upon submission. Any pending input will be lost.

  25. How do I find Open Access documents and journals in Scopus?

    Perform a Document search.The Document search results page opens. From the Document search results, from the Refine results panel, select the desired Open Access filter: . All Open Access: All documents that fall within any of the Scopus Open Access filters. Gold: Documents are in journals which only publish open access. Hybrid Gold: Documents are in journals which provide authors the choice ...