Once literature searches are executed, the adequacy of the searches should be verified and a literature search report should be compiled to present details of the execution, any deviations from the literature search protocol, and the results of the search. These data are best summarized in a data extraction table.
Literature reviews must be performed in a systematic manner. These reviews often involve a data extraction step wherein relevant pieces of information from the assessed studies are extracted in an organized manner to help analyze data and draw conclusions. Typical study parameters extracted include title, author, year, journal, aim, disease condition, patient population, follow-up duration, device used, performance outcomes, safety outcomes, study conclusion etc.
Presenting the extracted data in a tabular format allows for easy identification of key outcomes for reviewers and Notified Bodies alike. The tabular format also helps prepare for subsequent statistical analysis, if required. The data extraction table can either be attached as an appendix to the main document or be included as a part of the main literature section. This must be followed by a summary of the observed outcomes and overall conclusions from the dataset reviewed. Data extraction, while necessary, does require significant time and the process is prone to errors when performed manually.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][wd_hustle id=”18″ type=”embedded”/][/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Key Pain Points with Data Extraction Tables[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Medical writers may need to keep multiple tools such as PDF files, Microsoft word files, Excel sheets with extracted article metadata open separately to extract data from the article. Manual data extraction features in our 101 Ways to Waste Time in a Systematic Literature Review. Frequently switching between multiple windows with manual checks such as ensuring that data is being extracted for the correct article can make this a time-consuming process. Moreover, this step is often preceded by another manual step where article metadata is extracted using an external software (reference management software are popular choices) or done manually (points casually at junior associates).
Pssst! Did you know CAPTIS can help you extract PubMed, Google Scholar, Europe PMC, Embase, Cochrane and Prospero article metadata with just a few clicks? Chat with us to learn how.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Data Extraction Tables Within CAPTIS[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]At Celegence, we understand operational challenges faced by device manufacturers and medical writers alike and use technology to overcome these. CAPTIS helps cut short the overall time for a systematic literature review in many ways.
CAPTIS allows you to easily configure custom data extraction tables for your literature review. You can choose between simple text boxes or configure a dropdown list of options to choose from when extracting data. Additionally, you can set up “Help Messages” for yourself or your team to have guidance handy whenever needed.[/fusion_text][fusion_imageframe image_id=”15699|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Data Extraction Tables – CAPTIS – Add Data Field” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” 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text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Data fields configured in the project settings can be saved as a template for reuse and appear on the right-hand side option panel when reviewing articles.[/fusion_text][fusion_imageframe image_id=”15700|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Data Extraction Tables – CAPTIS – Screenshot” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”left” caption_title=”” caption_text=”Title and Abstract review summary” caption_title_tag=”div” fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/01/Data-Extraction-Tables-CAPTIS-Screenshot.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Data extraction on CAPTIS is faster than the manual method since bibliometrics information (i.e., publication types, journal names, authors, year of publications) of your entire project library is already stored in CAPTIS. The settings menu allows you to select which information to present for each article in your final data extraction table. The extracted data can be downloaded in the form of a tabular report for further usage.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ 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filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Benefits of of Data Extraction Tables within CAPTIS[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]
Here are some of the ways medical writers can save time using the data extraction table feature within CAPTIS:
Customized data extraction – Users can set which data fields they want to collect for each article
Set up templates on CAPTIS – All team members follow the same format for data extraction, maintaining consistency and quality.
Summarize as your review – Data extraction options are right next to the article when performing literature reviews, allowing you to capture data as you review
Single window approach – This web-based application displays all that you require for your literature review and extraction on the same platform, eliminating the need to open and switch between multiple application windows
CAPTIS as a repository – The entire literature review and associated extracted data will always be on CAPTIS. This provides a centralized place to access your literature reviews, replacing excel sheets, documents, and system folders. Review data can be exported on demand in multiple formats, making CAPTIS an excellent archival tool.
Presenting the results from a Systematic Literature Review is not limited to presenting the included articles in the Clinical Evaluation Report (CER) or Performance Evaluation Report (PER) or any other regulatory document that you draft. A systematic literature review should include a few additional elements of data such as:
The search strategy
Results from the Title and Abstract (Level 1) Screening process
Results from the Full-Text Evaluation/Appraisal (Level 2) process
A pictorial presentation summarizing the literature review, e.g., a PRISMA flow chart (optional but recommended)
A tabular presentation is the best way to present points #1 to #3 stated above. Tables can lay out individual articles and their review decisions in separate rows making it easier for the viewer to grasp information. Microsoft Excel is a good tool if you’re tracking the review manually. However, manual tracking has its own problems, the most significant being human error.
Ever had one of these thoughts when tracking or performing your literature review?
“The total articles in this list don’t match the number I got when I ran this string.”
“These entries look jumbled.”
“……a random empty cell. Hmm. Where is my data?”
Worst case scenario, your Excel crashes, and none of your hard work was saved.
You may also be performing a systematic literature review for the first time and may not be aware of ways or formats to use to display your review process.
[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][wd_hustle id=”18″ type=”embedded”/][/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Automatic Literature Report Generation Within CAPTIS[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]At Celegence, we understand the operational challenges faced by device manufacturers and medical writers alike and use technology to overcome these. CAPTIS significantly cuts the overall time for a systematic literature review in many ways.
CAPTIS automatically pulls in article metadata from your saved searches, identifies and removes duplicates, and gives you a prepared list of articles ready for review. CAPTIS also allows you to run your PubMed, Google Scholar and Europe PMC searches on the platform itself, and helps you save literature data from searches conducted on Embase, Prospero and Cochrane along with the search parameters used.
Since it stores all search parameters for all the searches you run, it essentially knows your entire literature search strategy and can present the same in a ready to use tabular report like the one below which can be exported out.[/fusion_text][fusion_imageframe image_id=”15592|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Automatic Literature Report Generation – CAPTIS” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2023/01/Search-Parametres-Automatic-Literature-Report-Generation-CAPTIS.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Similarly, it also generates other ready-to-use reports for presenting various aspects from your literature review.
Here are some of the ways medical writers can save time using the automatic literature report(s) generation feature within CAPTIS:
Consistent reporting for all literature reviews.
Traceable screening and full-text appraisal decisions.
Centralized place to access your literature reviews – Have your entire literature review right from literature search to appendix generation on CAPTIS instead of multiple excel sheets or documents.
Time and effort savings by having CAPTIS generate ready-to-use literature tables for your documents.
Easier maintenance and periodic updates of systematic literature reviews.
As part of the Clinical Evaluation process for a medical device, manufacturers are required to analyze broadly 2 types of data. One, which is held by the manufacturer, and another one which comes from various external sources, including published scientific literature, which can often form the bulk of this dataset. Apart from literature data, several publicly accessible Medical Device Safety Databases are available which can provide valuable post-market data to monitor device safety and performance.
Defined as a part of a medical device manufacturer’s Post Market Surveillance (PMS) plan, complaints with incidents where the device malfunctioned or caused a death or serious injury are to be reported to the country’s regulatory authority, along with any device recalls or safety notices published by the manufacturer. These then subsequently get published on country-specific medical device safety databases as Reports, Recalls, Safety Alerts or Field Safety Notices. In the United States, the regulatory authority Food and Drug Administration (FDA) maintains several Medical Device Databases. The Manufacturer and User Facility Device Experience (MAUDE), Total Product Life Cycle (TPLC), and the FDA Recall databases are some sources to dip into when finding external PMS data on your device. In this post we’ll discuss the our FDA MAUDE / TPLC Integration and how you can benefit from it.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]FDA MAUDE Database[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The FDA MAUDE database contains reports of adverse events involving medical devices marketed in the United States. The data consists of all voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. Incidents in these reports may describe suspected device-associated deaths, serious injuries, and device malfunctions, with a wide range of causes (e.g., from manufacturing to usability issues).[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][wd_hustle id=”18″ type=”embedded”/][/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]How to Search Data (Data Gathering) in MAUDE[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Data can be extracted from MAUDE by three methods:
Using the Simple Search to search by single words or phrases
Using the Advanced Search to search by Brand Name, Manufacturer, Event Type, 510K Number, PMA Number, Product Code, or date, or
Variations in the “Brand Name”: Brand Names on MAUDE are not standardized, which leads to variations in the way the brand name for the same device is reported across multiple reports on MAUDE. Consider a device with the brand name XYZ-Plus. MAUDE may have reports for the same device under the following brand names: XYZ-Plus, XYZPlus, XYZ Plus, etc. Also considering possible spelling errors by reporters when submitting these reports to MAUDE, one must search for all possible variations of the brand name when searching for device names with multiple words.
Multiple Product Codes: You can only search for one product code at a time. While this is fine for standalone devices, device systems with multiple components can include multiple product codes, which means multiple searches to cover all device components.
Singular Searching: MAUDE allows you to enter only one product code, brand name or manufacturer name at a time when using the Advanced Search option. This translates to individual searches for each brand name in scope if writing a CER for a device family. Also, considering searches for similar devices and challenges with brand name variations (see #1 above); that’s a lot of searches to be conducted!
Limitations around >500 results: The MAUDE database does not display or allow you to download more than 500 results in one search; MAUDE displays the following error message “500 records meeting your search criteria returned. The results are incomplete – please narrow your search.” To overcome this issue, one can split the date range into smaller pieces, download individual excel exports and stitch the data to get a complete dataset. This requires a level of manual effort and can be a potential source of error.
Challenge: Cannot search for multiple product codesin MAUDE directly.
CAPTIS Solution: Multiple product codes can be configured in the project settings within CAPTIS and you can search for the entire device system in the same search.
Challenge: Singular searching; cannot search for multiple brand names/manufacturer names in MAUDE directly.
CAPTIS Solution: Apart from multiple product codes, CAPTIS allows you to select multiple brand names and manufacturer names at the same time. One can save considerable time by searching for the subject device(s), the equivalent device, and similar devices, all in the same search.
Challenge: MAUDE does not display or allow downloads of more than 500 results.
CAPTIS Solution: CAPTIS has no limitations with respect to the number of results. One can view and download >500 results in the same search without having to split the date range or download and combine multiple excel sheets.
Fun Fact: One of Celegence’s recent clients had about 58,000 results on MAUDE! CAPTIS saved a considerable amount of time for the medical writing team by eliminating the need to split the date range, download and compile more than 100 excel sheets of 500 results each.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]TPLC – Total Product Life Cycle[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Total Product Life Cycle (TPLC) is a database within the FDA catalogue, which integrates premarket and post-market data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. A particularly useful feature within the TPLC database when doing FDA Product Code searches is the Device Problems table which provides an overall count of all Device Problems reported for a Product Code within the defined time period.[/fusion_text][fusion_imageframe image_id=”15465|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”4. TPLC – Total Product Life Cycle – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/12/4.-TPLC-Total-Product-Life-Cycle-Celegence.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
However, TPLC does not provide you an option to export this table in any format. The only way to export this data from TPLC is to manually copy and paste individual line items at a time, which is time and effort consuming.
At Celegence, we developed the TPLC integration feature alongside MAUDE on CAPTIS to eliminate the manual efforts required from medical writers to gather the data they need, saving time and improving their efficiency.
CAPTIS allows you to copy and paste the TPLC table with just a click of a button.
CAPTIS allows you to configure your TPLC report and to choose the brand names you are interested in. Along with the “Category Total”, CAPTIS provides you “Device Specific” totals indicating the number of reports for your chosen device(s) vs total reports for the entire product code.
CAPTIS gives you a ‘results cut off’ feature in the TPLC report configuration. This dynamic feature allows you to define a “cutoff point” enabling you to filter and view only those device problems which have a defined minimum number of reports.
Systematic Literature Reviews typically follow a 2-step process for screening literature. Step 1, where you identify relevant articles based on the title and abstract, and Step 2, where you investigate the full text of the identified articles for further analysis. While titles and abstracts are free to view, full texts papers are often not.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Key Pain Points[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A lot of published research is open access and is freely available for public consumption. But this is not always the case, as some research may be published in traditional closed access (subscription-based) journals, and readers are charged a certain fee for access to the articles.
To conduct a robust, unbiased literature review, one must consider all relevant sources of data, open access or not. As a medical writer conducting literature reviews for a client, you may send the list of paid articles to your client, or if your organization conducts literature reviews in-house, you may have a separate team or process to procure these paid articles.
If you’re an experienced reviewer, you’d be familiar with the manual work and logistics behind a systematic literature review. This blog will focus on the logistics of identifying free vs paid articles and the associated archiving, post the title and abstract screening. Below is an example of a typical workflow:[/fusion_text][fusion_imageframe image_id=”15229|full” max_width=”” sticky_max_width=”” skip_lazy_load=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Automatic Full-Text Retrieval – CAPTIS Feature – Graphic 1″ link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/11/Automatic-Full-Text-Retrieval-CAPTIS-Feature-Graphic-1-Celegence.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Now, let’s focus on the light blue arrow in the process flow above and estimate the manual effort behind progressing to full-text evaluation post the title and abstract screening stage.
While many organizations have an internal repository of articles or subscriptions to paid journals, literature reviews for regulatory submissions such as Clinical Evaluation Report (CER) or Performance Evaluation Report (PER), must be submitted with full texts of all sources referenced in the document. Hence, the task of compiling a report-specific folder/location with PDFs of included literature references still remains.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][wd_hustle id=”18″ type=”embedded”/][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Automatic Full-text Retrieval Within CAPTIS™[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]CAPTIS™ helps cut short the overall time for a literature review in many ways. Apart from automatically pulling in article metadata in your review dataset from sources like PubMed and Google Scholar, it also retrieves, renames, and stores any freely available full-text once the article is included in the title and abstract screening step.
In short, the tiresome process of searching for, downloading and storing full-text documents can now be eliminated.[/fusion_text][fusion_imageframe image_id=”15217|full” max_width=”” sticky_max_width=”” skip_lazy_load=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Automatic Full-Text Retrieval – Systematic Literature Reviews – CAPTIS” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/11/Automatic-Full-Text-Retrieval-Systematic-Literature-Reviews-CAPTIS.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Using a unique built-in filter for article availability, CAPTIS™ automatically assigns tags to all records with missing files and allows you to filter them out using the Missing Article filter. This filtered list can then be exported out as an excel and shared with the concerned team for article procurement.
And once those missing PDFs are available, you can simply upload them back to CAPTIS™ on to their respective records. These PDFs will now be available for your current full-text review stage and any future reviews/cloned projects utilizing the same project.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Benefits of Automatic Full-text Retrieval within CAPTIS™[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Here are some of the ways medical writers can save time using the automatic full-text retrieval feature within our EU & IVDR compliance tool CAPTIS™:
Automatic identification and tagging of free vs paid articles: Writers need not check if full texts are freely available or not. CAPTIS™ does the background work for you and provides filters such as Missing Article to highlight which articles are missing PDFs
Automatic download and renaming of available articles: CAPTIS™ automatically downloads, renames and attaches PDFs to relevant articles. This negates the logistical challenge of keeping articles/PDFs in the correct location, and in a singular format.
Uploading articles: Manual uploads are automatically renamed by their CAPTIS™ article title, keeping the naming convention uniform throughout the project.
Storage and download: All PDFs are attached to their respective record on CAPTIS™ and can be downloaded in a zipped folder when needed.
In vitro diagnostics (IVDs) have always been an important part of the healthcare industry. However, historically this sector has tended to be overshadowed by the medical devices sector, both in the public consciousness and in the regulatory space. The COVID-19 pandemic changed this situation, with the ubiquitous use of Lateral Flow Tests (LFT) and Polymerase Chain Reaction (PCR) tests playing a significant and visible role in the public healthcare response. During the pandemic and ever since, the industry has come into the limelight and its role has received greater recognition, both from the public and regulators.
During the pandemic, the regulatory framework for European CE Marking underwent tremendous change, with significant impact on manufacturers. Following several years of development, the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, known as the ‘IVDR’, was published in April 2017. On 26th May 2022 this regulation entered into force, after a transition period of five years. This replaced the IVD Directive (IVDD), which had been in place since 1998. One key change it introduced was the way in which devices are classified. Correct classification is the very first step in the process of regulatory compliance. Therefore, it is important that manufacturers must first understand this new system and then apply it to their own devices.
Under the IVDD, devices were classified using a “List based” approach. Two lists, (List A and List B) of categories of assays for specific medical conditions or pathogens were used to classify some products for higher levels of regulatory scrutiny, including the involvement of a Notified Body. Product classification was achieved in part by reference to these lists, leading to selection of the appropriate conformity assessment route, detailed in the Annexes of the Directive. Where not listed by assay type, IVDs for self-testing were also subject to similar conformity assessment requirements to List B products, giving four possible classifications under the IVDD:
Annex II, List A: This list has products, Reagents, calibrators, and controls including –
Products identifying blood borne pathogens like HIV, HBV, HCV, HTLV-I/-II well as the detection of variant Creutzfeldt–Jakob Disease (vCJD). These are the highest risk products.
Annex II, List B:
Products for blood groups (anti-Duffy and anti-Kidd); irregular anti-erythrocytic antibodies; rubella and toxoplasmosis; phenylketonuria; cytomegalovirus or chlamydia; tumor marker PSA; determination of HLA tissue types DR, A, B; for the evaluation of the risk of trisomy 21, including software; products for self-diagnosis of blood sugar levels, including instruments.
Products for self-testing: e.g. Pregnancy tests, (see Article 9 and Annex I, Section 7)
General IVDs: Products not listed above are all classified as “General IVDs”. These did not require the involvement of a Notified Body for obtaining the CE mark.
The IVDR has brought in a “Risk based” approach as against the earlier “List based approach”. This classification is based on a GHTF guideline (GHTF/SG1/N045:2008), thereby it aligns with international best practice. The objective of this system is to improve patient safety. Although IVDs do not typically have the potential to cause direct harm, as may be the case with other medical devices, they do have the potential to cause indirect harm. For instance, an erroneous false positive or false negative result may lead to incorrect diagnosis and incorrect treatment leading to harm to the patient of varying magnitudes. For example, consider the impact of an incorrect test result for COVID-19 or for HIV.
Devices are now classified into four classes- Class A, B, C, D (highest) depending on the risk of the product. Only Class A products do not require Notified Body oversight. Under the IVDR, more than 80% of the IVDs will require notified body approvals, as against the 20% IVDs under IVDD!
Therefore, before considering CE marking, it is imperative that manufacturers revisit their device’s classification under the new rules and the implications of up-classification is huge!
High risk to the patient and a high risk to public health
Detection of Life threatening, transmissible pathogens intended to be used for transplantation or transfusion. Egs., HIV- I/II, HBC, HCV, blood grouping
Class C
High risk to the patient and/or medium risk to public health
Varied products such as high risk diseases, tissue compatibility tests, sexually transmitted diseases, cancer testing, genetic testing, pre-natal testing, companion diagnostics, screening tests, some self- testing devices
Class B
Moderate individual patient risk and/or low public health risk
Self-testing IVD devices for pregnancy and fertility testing, detection of cholesterol, erythrocytes, leucocytes and bacteria in urine. Also controls without a quantitative or qualitative assigned value
Class A
Low risk to the patient and low public health risk
Specimen receptacles, Instruments and general purpose reagents, buffers or stains used for diagnosis
Annex VIII of the IVDR details the classification system which comprises ten implementing rules and seven classification rules. IVD devices, accessories, software, equipment, reagents, calibrators, controls are all covered by the new system. Both these sets of rules are to be used for identifying the class of a product. A critical factor in determining a device classification is the intended purpose, therefore it is important to have this clearly documented.
It is the manufacturer’s responsibility to classify its products. The first step is to write down clearly the intended purpose of the device. This should also consider factors like indications of use, the user, their technical expertise, and also the patient group. Such a detailed intended purpose then can help identify the right class of the product. After the class of the product is identified, the conformity assessment route can be selected, based on which, the technical documentation and all other requirements can be identified and fulfilled. The risk class appears on the Declaration of Conformity. It is to be included in the Technical Documentation along with the justification, the rule and sub-rules applied.
Applying the rules can sometimes lead to ambiguous situations. For instance, a PCR general purpose reagent would be Class A, but when it is used specifically for detecting HIV virus, it can be a Class D or a Class C product. When resolving such issues, it is always advisable for the manufacturer to confirm proposed classifications are acceptable at an early stage with the Notified Body. There is some guidance available such as –
MEDDEV 2.14/1 Borderline and Classification issues – a guide for manufacturers and notified bodies.
Classification Rules for IVDs has been issued for the IVDR: MDCG 2020-16
Qualification and Classification for software: MDCG 2019 – 11
Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant device expertise to complete this type of work for you or supplement your internal teams as needed. Our team of IVDR experts would love to partner with you in delivering regulatory compliance end-to-end. For more information, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.
Dr. Anita Joshi is a Biotechnologist with 10 years of research and academic experience, including a Ph.D. (Biotechnology) from the National Institute of Virology (NIV), Pune, and Pune University. She also has 20+ years of BioPharma-Healthcare Industry experience in assignments with reputable commercial organizations. Anita has worked with more than 85 organizations since 2001 including: Span Diagnostics Ltd., Thermo Fisher Scientific, Merck Millipore, HCL technologies and more. She has been an auditor with BSI for ISO 13485, MDSAP, GMP etc. for the past 14 years. To date, Anita has 41 publications.
Maintaining Literature Reviews & Editing Search Strategies – CAPTIS™ Features
[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]“It’s all fun and games until you’re revising your Literature Search Strategy”[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
You’ve done literature reviews before and you’re confident you’ll nail this one too. Your research objectives are clear, with multiple search strategies in mind. You know which databases you’re targeting and are positive that your chosen date range will return enough relevant articles for you to write your report.
The first stop is PubMed. You run your search parameters, and satisfied with what you see, you extract the data into an excel sheet so that you can screen all your literature together later on. You run your next PubMed string(s), extract and save the results again.
Move to your next database. Rinse, and repeat.
You’ve now extracted data from all your search strings, the excel sheet looks proper, column headings are where you want them to be. Today has been productive.
However, midway through your screening you notice that you haven’t identified many relevant articles yet. And as you progress through the 2nd half of the list, the status remains unchanged.
Your determination doesn’t falter, but reality soon sets in that you won’t have enough relevant articles for your report!
You must revisit your search strategy (and perform the laborious task of data extraction for ALL your strings, again). As your colleagues are wrapping up their workday, you stare hopelessly at Microsoft Excel, and wish for a miracle.
Typical symptoms of theI don’t want to do this againsyndrome commonly seen in medical writers. Where junior writers and interns are the most vulnerable.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Manual Date Range Extension[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Assuming your original date range was from 01-Jan-2018 to 31-Dec-2021, this is what you will probably do:
Extend your search range by a couple of years: it now is 01-Jan-2015 to 31-Dec-2021
Search for the additional date range 01-Jan-2015 to 31-Dec-2017for all the search strings, maintaining the same filters
Stitch the new results to your existing data set individually for each string
This should work, right? Unfortunately, not quite. In the pursuit of maintaining a continuous date range of 01-Jan-2015 to 31-Dec-2021 within your report, you will be faced with challenges when extending the search date range manually. Let’s take an example:
String Type and Date Range
Search String
Results
Original 01-Jan-2018 to 31-Dec-2021
(primary focus of the research)
“left atrial appendage” AND (closure OR occlusion) AND imaging AND 2018/01/01[PDAT] : 2021/12/31[PDAT] AND (eng[Language])
Looking at the example above, stitching individual date ranges together does not always give you the same results as a continuous date range. Presenting results from a stitched dataset as results from a continuous date range string is incorrect as you will not be able to replicate the same number of results when you run the continuous string. Repeatability is the core of a search strategy; hence, mismatched results would deem your search strategy inaccurate.
Make the necessary changes – in this case, let us expand the original date range of 01-Jan-2018 to 31-Dec-2021, to 01-Jan-2015 to 31-Dec-2021. CAPTIS™ now shows us the 849 results that PubMed gives us when running the continuous date range.
And what’s more, if your original data set was reviewed already, you can still go back and edit your searches and CAPTIS™ will present all the new articles under “Actions Pending”, so that your original reviewed dataset is unaffected.
Manual work for medical writers to stitch the data back into the master data repository/dataset. This also involves a significant amount of pre-processing/formatting when combining differently formatted literature outputs from different databases.
Mismatched results: Stitching outputs from two date ranges for the same search string does not give you the same number of results as a continuous search. Another level of verification is needed to match the outputs from continuous date range.
Inaccurate search strategy: Presenting results from a stitched data set but presenting the same for a continuous date range in the report will deem your strategy inaccurate due to mismatched overall search results.
Hassle-free updates to the search strategy: The quest for evidence for a Clinical Evaluation Report, Performance Evaluation Report or any reports utilizing a literature output can be continued without worry with CAPTIS™ enabling you to add additional years to your date range with just a few clicks.
Easily extend date ranges: Users can simply update the date range of a saved search and CAPTIS™ will automatically pull all additional articles and present the results accurately as a continuous date range without any manual data-stitching.
Update saved searches but retain review decisions: Users can update saved searches even if the articles from the original searches have already been reviewed. New articles can be easily filtered out and reviewed.
Save Time with Smarter Report Maintenance: Combine the search editing features in CAPTIS™ to save time on the overall literature review for a maintenance report if you have overlapping date ranges. CAPTIS™ enables you to clone entire projects including the literature datasets and review decisions. Clone the previous projects, edit the date ranges of the previous search strings, retain review decisions of overlapping articles, and save time by reviewing only new articles.
Literature searches are a key part of clinical evaluations, usually involving countless hours of work. Medical writers and clinical experts compile scientific publications as a part of their literature review for various reasons ranging from gathering evidence for claims made on the device, documenting the state of the art and most importantly, to provide proof of the reliability, effectiveness, and clinical value of the device under evaluation.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Literature Search Strategy[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Any gaps that clinical data cannot answer must also be covered in the literature review. In order to uncover relevant literature and evaluate it, a librarian or a medical writer with knowledge of choosing the right search keywords and experience using scientific research databases like PubMed or Embase must be involved.
For regulatory documents created to satisfy requirements of the EU MDR or IVDR, one of the key components that notified bodies are interested in is your literature search strategy.
A search strategy is a plan to find relevant literature, including details of the databases searched, and the keywords and search filters used. There must also be a systematic and unbiased way of analyzing said literature which essentially translates into the inclusion and exclusion criteria used in the title and abstract screening, and the appraisal method used in the full text evaluation.
While one can use focused searches, i.e., input keywords in a database and pick articles that seem relevant, this is not a systematic approach and may result in an observation from the Notified Body citing risk of bias. Cherry-picking evidence is a crime in the regulatory world and re-doing your report’s literature section within your notified body response time will take time and effort (and blood, sweat and tears).
To have a more focused and smaller literature dataset to review and to get to your relevant literature quicker, writers should use search strings instead. Databases like PubMed allow combinations of multiple keywords using Boolean operators such as AND, OR, and NOT which can greatly reduce the number of hits and give you more refined and productive results.
Apart from search strings, other parameters can come into play when building a search strategy, such as the chosen date range for the clinical or performance evaluation. A defined start and end date range helps you get to the latest research and limit the number of overall hits. You can also use filters for article types such as meta-analysis, systematic review, clinical trial, review etc. depending on the type of publications you’re interested in.
While there are no limitations on the filters used when searching PubMed, ensure that your search strategy is not limiting and returns a sufficient number of articles to review. Needless to say, a “sufficient number” is subjective and will depend upon various factors such as the device’s time in the market and it being a popular topic of research. However, do not forget that the goal of a literature evaluation is to provide an unbiased picture of the device’s safety and performance in the market, and not to have a comfortably small literature dataset to review.
Another key feature of a literature search strategy is its reproducibility. One should be able to arrive at the same literature dataset even if the same search parameters are run on a different date. Hence, the strategy must be documented accurately.
Below is an example of a record of a search strategy which includes the database searched, date of search, search terms, all the filters used, and the applied date range. Recording the search strategy is an integral part of the report writing process and serves as the backbone of the literature review within your clinical evaluation or performance evaluation.
(((head OR neck OR brain OR cranial) AND (tumor OR lesion OR cancer) AND (radiotherapy OR “radiation therapy” OR teleradiotherapy OR teletherapy OR “external beam radiation therapy” OR “IMRT” OR “intensity modulated radiation therapy” OR “VMAT” OR “volumetric modulated radiation therapy” OR “SRS” OR “Stereotactic Radiosurgery” OR “image guided radiation therapy” OR brachytherapy OR “3D conformational radiation therapy” OR “helical tomotherapy”)) AND ((trial OR “meta-analysis” OR “metaanalysis” OR “Systematic review” OR “SES”) AND (patient OR clinical))) NOT (breast OR prostate OR lung OR pancrea* OR hepatic OR Cervical OR stomach OR colon* OR renal OR liver OR spine OR spinal)
Language: English
Only human studies
Article type:
Clinical Trial
Systematic Review
Randomized Controlled Trial
Meta – Analysis
From Jan 01, 2018 to Dec 31, 2021
460
PubMed
Mar 27, 2022
(chemo* AND surgery AND radio*) AND (“head and neck” OR brain) AND cancer AND (“Tumor control” OR “Tumor volume reduction” OR “Survival rate” OR “Mortality Rate” OR “Recurrence” OR “quality of life” OR “Progression free survival”)
Time Consumption: As soon as the search parameters are finalized, one must promptly record all elements of the search in a separate document or an excel sheet. Oftentimes, highly skilled team members are spending many hours collecting these data elements and making them uniform in a spreadsheet.
Human Error: Human error can occur when copying and pasting search strings; even a missing filter or quotation mark would mean that your record of the search strategy is inaccurate, and the search is no longer reproducible but with the CAPTIS™ PubMed integration human error is minimized.
[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]PubMed Integration Within CAPTIS™[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The PubMed Integration is a native feature within the CAPTIS™ platform; i.e., users can search PubMed directly via the CAPTIS™ search module, similar to the Google Scholar Integration. If you conduct your literature searches through CAPTIS™, all search elements including the date of the search, filters used etc. are recorded by the platform and a search strategy is automatically documented within your project. This strategy is available in the form of a report which can be easily exported and plugged into your CER or PER or any other document utilizing a literature review.
Experienced literature reviewers will acknowledge that compiling literature results is a trying task. But it doesn’t have to be.
CAPTIS™ imports all article identifiers like the article title, authors, publication details, abstract, and links to the original PubMed article automatically. In addition to that, it also deduplicates the list of articles for you; hence, there are no secondary exports or steps required to fully document the process and users can begin their literature evaluation immediately. CAPTIS™ handles the mundane aspects of a literature search for you, so that you can focus your time on the actual analysis involved in the systematic literature review.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Benefits of using PubMed Integration within CAPTIS™
Here are some of the benefits of using the PubMed Integration feature within CAPTIS™:
Direct Integration: Users can search and save directly through CAPTIS™, and hence save time by not needing to collate results from multiple searches into a single document.
Automatic Record of Search Strategy: CAPTIS™ accurately records all the search parameters used when running a search and presents the same in the form of a ready-to-use report.
Simplified and Automatic Import of Abstracts: PubMed CSV exports do not contain the abstract field. Writers must utilize other tools to obtain and compile abstracts to their master screening list of articles. CAPTIS™ automatically imports all article abstracts and allows users to export the entire dataset in a CSV format, if required.
De-duplicated Data: The advanced de-duplication algorithm within CAPTIS™ ensures that you always have a duplicate-free list of articles to review.
By replaying this webinar, you will have an opportunity to understand the best practices to determine valid clinical performance or safety claims with measurable benefits, identifying clinical endpoints or surrogate endpoints, to demonstrate conformity with General Safety and Performance Requirements (GSPRs) for MDR compliance.
If you were not able to attend this webinar, here’s a link where you can watch the on-demand version or embedded below. We are here to address any other questions that you may have related to the webinar, or questions.
This post contains the Q&A session from the webinar – giving you the answers to the most common questions that were asked about medical device claims.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
A full transcript of Smridula’s presentation is available to download (and to read below) and just press play to watch the clip now.
A: The classification of claims presented is a general practice worldwide, it is not specific to a particular region. There are other ways of classifying claims as well, for instance competitive claims, efficacy related claims etc.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Do you see a difference between clinical claims made by marketing, which may be specific and numerous, versus benefits in the CER? If so, how do you see the relationship between specific clinical claims used by marketing versus broader benefit claims in the CER?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]For example, a wound dressing where the benefit is healing wounds, but marketing wants to differentiate based on multiple, more specific claims, such as reduces damage to wound during removal.
A: So usually what we’ve seen is if the marketing team wants to split it into multiple benefits, they can do that, provided it maps to one umbrella claim within the CER. So, in this case say you’re talking about different types of wounds that can be healed by certain dressings or in different locations, that type of claim is fine. You can call out different locations within your marketing material and just say heals wounds within the CER. But like I said, all claims should map to a specific umbrella claim and you should have proof within the umbrella claim that supports all of these individual claims as well. If it does not support one particular statement within your marketing material or within your literature provided with the device (Brochure/ IFU) then that must be taken off because we have seen instances where the notified body has pointed out claims in the marketing material that aren’t a part of the CER and since it isn’t a part of the CER where is the proof that you have clinical data that supports it, and we want you to change it.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Can you explain the differences between claims and clinical benefits with an example?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: Example – you are claiming lesser revascularization procedures when you use a Device under evaluation- which is a stent. That’s a claim and your benefit to the patient is that they will have less time under general anesthesia, which means less surgeries, less risk, and less reoperations. That’ll be the benefit to the patient. Similarly, for a device, which is a bone hemostat, my claim would be that it is completely re-absorbable by XX amount of time (say within 6 hours, within 16 hours or within a day). The benefit would be that the risks associated with the non-resorbable hemostat such as granulomas or infections are reduced. So that is the benefit. And your claim is that it’s resorbable.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Is there an overlap between intended use claims and clinical benefit?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: Intended use is what your device does. In many cases the intended use itself translates to a claim – “my device performs XX without any unacceptable adverse effects”. There are also scenarios where claims are what enable your device to achieve its intended purpose, for example a radiation device where you are calling out the dose accuracy or dose rate as one of the claims. The clinical benefit is related to the clinical claim and intended purpose in the sense that it is the effect that the intended purpose or the specific claim has on the patient or the user.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Is there an example or guidance with an example of the type of performance or safety claims?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” 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A: The MedDev 2.7.1 Rev 4 gives you very detailed guidance on what type of claims you should have and what the nature of the claim should be, what are measurable and quantifiable, but it doesn’t have examples. It gives you pretty detailed guidance on what you should consider for claims. The MDCG document does give you very few examples on direct and indirect benefits, but not claims.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: During an annual update of a CER can we use the clinical literature data for a particular safety or performance as a claim?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
A: Yes, your clinical literature data can be used to supplement safety and performance claims within a CER.
A: Not really. There are cases where a diagnostic device can have a direct claim. If the diagnosis is directly resulting in identifying or a life-threatening condition or a disease that requires immediate treatment, then it is a claim with a valid clinical outcome. For example, a device that measures heart rate, and it identifies arrhythmia. So that is a diagnostic device, but with a direct claim. You can say that identifying the arrhythmia helps you prevent any sequelae from having prolonged arrhythmia.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: On websites and in marketing material, we often refer to the latest publications with data on our device including off label, will this no longer be allowed unless it is included in clinical evaluation report first?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A: It’s not disallowed. You can have data on your website that supports an off-label use, but you ideally should not be claiming it until you have enough proof for that particular off-label use. You cannot use it as a part of the intended use, and you cannot claim it as something your device does. You can say that these are publications that support the use of the device in different situations, with a disclaimer that it is not recommended for this purpose but there are papers which demonstrate that it has been used favorably in these situations. To sum up, unless you have supported a claim in your clinical evaluation, and it has been approved by the notified body, it cannot be used as a direct claim in your marketing material either. You can mention that it is an off-label use, which is supported by these publications.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” 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filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Q: Is it mandatory to cite claims in every CER or CEP?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” 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A: The objective of having the CER is to show that your device is useful and does something. So, it is mandatory to demonstrate clinical benefit, either direct or indirect and without that the notified body would come back with questions regarding the purpose of your device. We have earlier submitted documents that said we have no claims, to which the notified body came back and said, if your device doesn’t have a purpose, if it doesn’t have a benefit, then why is it even in the market? So, identifying the purpose of your device, and identifying what it does for patients or for users is mandatory. You must have it as a part of the CEP and the CER for it to make sense to have your device in the market. Your claim can simply be that your device performs as intended and at par with the state of the art, you have to demonstrate this in your CER and show what benefit is associated with the intended purpose.
A: I would say no, again. Somebody must be validating these claims. Somebody must be saying that there is sufficient evidence for these claims. So, if you are using it in your marketing literature on your website, and you’re saying these are literature supported, somebody has to say, this amount of literature is enough. So, if it’s not in the CER, who is going to verify if that data is enough, who’s going check if the amount of clinical evidence is enough? So, anything that is used for your marketing should be approved by the notified body, by the regulatory authority, before it goes on there as a valid claim. As mentioned earlier you can mention it as an off-label use that requires further evaluation but no concrete statements unless they are approved by the notified body through your clinical evaluation.
Smridula Hariharan is a valuable member of the Celegence team due to her expertise and highly successful career in Regulatory Affairs. She has 9 Years of medical writing experience including medical devices and In vitro diagnostics. Experience spanning different therapeutic areas and all the different risk classes of devices.
Webinar Background:
One of the major hurdles faced by manufacturers while creating MDR compliant CERs is identifying clinical safety and clinical performance claims and their associated measurable clinical benefits. Another hurdle is defining the end points that can be used to establish that the device in fact achieves these claims and benefits. There are several considerations when determining the claims and their end points.
During our webinar titled “Unveiling Impactful Methods to Strengthen Device Claims”, Smridula Hariharan, spoke specifically about the best practices to determine measurable claims, identifying clinical endpoints or surrogate endpoints, to demonstrate conformity with General Safety and Performance Requirements (GSPRs) for MDR compliance.
Why should you read the transcript/watch this video?
The transcript blog will focus on four important aspects that will help strengthen device claims and make EU MDR complaint CERs
Hello everyone. We’re going to talk about how to identify relevant claims for your medical device so that the notified body does not raise any questions on your CER or PER. This is applicable to both medical devices and invitro diagnostics. But from the presentation perspective, we’re going to focus more on the requirements of MDR today.
[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]EU MDR 2017/745, Article 7[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]I’d like to start off by just giving the definition of a claim as mentioned in the MDR. MDR article 7 says that the labelling instructions for use anything that cites what the intended purpose of the device is and gives the functions or properties of the device. If that ascribes to a function or a property, which the device does not have, or if it creates a false impression of either treatment or diagnosis or if it gives any kind of information that is misleading and may cause a risk to the patient who’s using the device, then it is actionable, and you cannot make such claims without having proof for it.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]MDR Annex VII, p. 4.5.5[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
The other point that you must consider is that the intended use as specified by the manufacturer and whatever claims surround the device is one of the most important points that are evaluated by the notified body when they check clinical evaluation reports.
Our goal is to understand how to best state and identify valid device claims. The next step would be how to identify evidence for these claims to show that these claims are valid, and we have proof that our device performs as intended.
Under the EU MDR (and the MDD) claims can come from any source. It is not limited to the operator’s manual or the IFU for the device, but any claim surrounding a device coming from any platform a website, social media, print, newspapers, anything is a valid claim. It is something that you should have evidenced for. If we do not have evidence to support this, then it is a problem and it should be taken down from any of these platforms so that it does not create any misleading information among the users.
You can see that print media, the company website, even advertisements that are run on TV are also actionable. If it does not have a claim that is valid, then it cannot be run on television as well.
There are different types of claims that you can make for a device.
Some of the claims are revolving around the safety of the device
Some revolve around the performance
Some are just technical claims
For the purpose of a clinical evaluation, your claim should be centered around clinical safety and performance claims.
Technical claims are related to the design features or something that the device can do that does not necessarily result in a clinical benefit. Those kinds of claims are technical claims. Since they do not have any benefit to either the patient or the user, it does not make too much sense to present them in a clinical evaluation report. Technical claims can always be presented in your technical file. But for a clinical evaluation, it’s usually restricted to clinical safety and performance claims.
The EU MDR Article 2-53 defines a clinical benefit as a positive impact that a device has on the health of an individual and it is necessary that these benefits are meaningful and can be measured.
Mainly because as I mentioned earlier, the goal of a clinical evaluation is to show that your device can achieve these clinical benefits. If they’re measurable and they have a meaningful outcome, that is the only way that you can prove that your device actually achieves these benefits or produces these benefits in the users.
Clinical benefit is slightly different from clinical performance, clinical performance is what the device does. It can be the same as the intended use of the device and then what impact this intended user, what impact this performance has on the patient is the clinical benefit.
For demonstrating your safety and performance claims, you must identify the clinical benefit that is achieved. And then you must identify the endpoints for these benefits and demonstrate these endpoints within your CER.
For the purpose of the CER, there are two types of benefits:
Direct benefits
Indirect benefits
The direct benefits are benefits that the patient can experience using the device directly. For example, guide wires assist other medical devices in achieving their intended purpose as such a guidewire does not have any medical benefit to the patient. It does not either treat or diagnose any condition on its own, but in combination with say a stent or another interventional device, it helps in revascularization, or it helps in delivering valves or any other type of interventional devices. So, on their own, they do not have a clinical benefit. They have an indirect benefit by facilitating the delivery of another device to the location that it is intended.
Identifying whether your device has a direct or indirect benefit is essential at the very beginning of your clinical evaluation. This helps you plan what type of data you should have to demonstrate that your device achieves clinical benefit. It also helps you to come up with justifications in case you do not have clinical data for your devices.
Under the GSPRs and to demonstrate compliance with the GSPRs, it is expected that all devices have clinical data, but there are exceptions to this rule. So, to identify if your device falls under these categories, which can be exempted and which need not have clinical data, it is essential to identify what type of clinical benefits are associated with your device. So, there are clinical benefits where it helps in managing a procedure and that procedure in turn has a positive impact on the patient. This is one of those cases where the device as such does not have a direct medical benefit to the patient. It only has a positive impact on patient management, and this cannot be demonstrated via clinical evidence except clinical evidence for the main device or the main procedure that is being conducted.
There are a couple of guidances and a couple of documents that help in determining what clinical endpoints are, what counts as a valid endpoint and what type of endpoints can be considered.
Section c gives detailed information on how clinical benefits can be identified. It gives information on how these endpoints for these clinical benefits can be identified. What factors you should consider.
For example, it is essential to consider the duration of the clinical benefit experience by the patient. Is your device resulting in a short term benefit, is your device resulting in a benefit that extends over years? If there is an improvement in the quality of life, how long is that expected to last? These are some of the things that you are expected to identify and call out within your clinical evaluation plan, and then demonstrate via suitable data in your clinical evaluation report.
So oftentimes it’s that identifying these endpoints becomes a little bit of an issue. We’re not very sure what kind of endpoints we should consider for each benefit. Here is the guidance and consensus documents around the clinical condition of interest that your device either treats or diagnoses. Then there are industry standards, again, for that particular clinical condition or procedure that your device does.
State of the art (SoTA) – State of the art is also another very important source from where you can identify endpoints. Let’s take the example of state-of-the-art. Let’s go with the example of a catheter. You’re talking about a catheter that delivers a stent and therefore helps in revascularization. So, what type of endpoints should you consider and how do you make them measurable? So, for a catheter, let’s say it’s fairly simple to assume that one of the endpoints should be a safety endpoint and would be that there is limited mortality, morbidity, there’s limited dissections associated with the use of your device. So, when you say limited, that endpoint is valid, so having less dissections or having less mortality is an endpoint, but it is not measurable.
How do you make it measurable by quantifying it by saying my device has dissections in the range of say 2%, 3%, 4%. So, adding a value beside that makes that endpoint measurable and quantifiable. Something that you can demonstrate via your data. So how do you come up with these values and percentages? How do you determine if these values and percentages are acceptable? If you say 50%, your device will obviously have detections less than 50%, but is that a good claim to make? Is that something that is valid? How you can determine that is to check the state of the art. So, say you identify a benchmark device, you go through the literature for this benchmark device, and see what kind of data is available for your benchmark device. If your benchmark device has a dissection rate of 4% or 5%, you can set that as your limit for your own device. Then you can look through your data, your own clinical investigations and the literature published on your device to check if your device has dissections that fall within this rate. So, that would be a valid claim and a measurable claim. Something that you can easily demonstrate via the data that you have. Going through state-of-the-art and industry standards is a very good way of identifying endpoints and quantifying them.
Industry standards also often provide values that you can use in your claims. For example, say you are considering a device that is used for radiation therapy. There are several standards that surround what is the safe dose rate that can be dispersed by a radiation therapy device. So that value you can consider as your endpoint. Then you can say that my device safely delivers this dose rate within so and so square meters or within so and so area. The industry standards also specify certain things like what is considered accurate and precise during radiation therapy or during radiation delivery by device. So, those are things also that you can cite in your performance objectives.
You can say that my device follows industry standards, meaning it delivers radiation within this particular range. It delivers with this accuracy, with this precision, and those values can be obtained from industry standards and consensus documents. Once you have those values, you can go through your internal documents to see if your risk management documents and your internal testing, as well as any clinical investigations that you have, support these claims.
There is a scenario where you cannot have direct clinical outcomes and therefore you cannot have direct clinical claims. These come into play when you are considering indirect benefits. So, as we mentioned earlier indirect benefits are for those devices where they do not have a direct effect on the patient. They are not directly involved in either the treatment or diagnosis of a clinical condition that a patient is experiencing. So, in that case, you have two options. One is to say that your devices success or your devices safety and performance objectives can be only demonstrated through the safety and performance objectives of the main device with which it is used. For example, a device that measures blood pressure during a dialysis procedure, the actual device that measures the blood has no diagnostic value. Neither does it have any treatment value. The value entirely depends on the device that is performing the dialysis, but you can say with data that helps identify the flow rate or the access flow rate through the dialysis machine, we are able to optimize the dialysis settings and therefore deliver the best dialysis therapy to the patient. It’s helping us optimize patient management. So how do you demonstrate optimization of patient management? That is not something that will have a clinical outcome that you can measure, that is not something that will have a quantifiable number that you can measure. So, in these cases is where you use something that we call surrogate endpoints.
Surrogate endpoints are basically laboratory measurements or physical signs in some cases, biomarkers that are used as a substitute for a meaningful endpoint.
In cases where we are not able to directly measure how the patient feels or how the patient is benefited by our device, we can use a physical sign or another laboratory measurement, which is an indication of this final endpoint that we are hoping to demonstrate. So, in the previous example that I had given a device that measures flow rate, I am saying that by accurately measuring flow rate, my device is helping to optimize the dialysis therapy. My surrogate endpoint is just accurate and reproducible measurement of flow rate. If I’m able to demonstrate that I can extrapolate that data to say that because I’m able to accurately and reproducibly able to measure the flow rate, I’m able to optimize dialysis and dialysis is associated with beneficial patient outcomes, which can be measured for the dialysis system on its own. So, you use a surrogate endpoint to demonstrate a final clinical outcome.
Now, for these surrogate endpoints, you obviously cannot have clinical data to demonstrate it. It is in these situations that you can call on the exception and use non-clinical data to demonstrate compliance with your GSPRs and to demonstrate that your device achieves its clinical claim or has an actual benefit. It’s only in this case that you can use non-clinical data. So, it is expected to be a measure of the therapy that you are delivering, and therefore it is considered a final endpoint in its own right, but for any devices, which do not have a direct benefit, it is only for those devices that you can consider a surrogate endpoint.
For devices which have a direct effect on the patient. There are very rare scenarios where you can use a surrogate endpoint, unless it is unethical to measure the final outcome and to have clinical data to support that there is no other scenario where you can use a surrogate endpoint for a device, which has a direct benefit or a direct effect on patient treatment or diagnosis.
Investigations that are either sponsored by the manufacturer or that you can find from external databases, these clinical investigations maybe investigator led, or they could be sponsored by another device, but has used your device as a competitor or a comparator. So those types of clinical investigations can be used
Published literature on humans
data from any registries where your device is being considered
data from another device, which is used a subject device which does not have direct clinical data
usability studies or human factor studies that have relevant data pertaining to your clinical endpoint
Types of Non-Clinical Data:
These can only be used for devices that do not have a direct clinical benefit and for which you have identified surrogate endpoints, and to demonstrate these surrogate endpoints, you can use non-clinical data.
These non-clinical data can either be obtained from
Bench testing/verification/validation studies
Pre-clinical studies that were conducted by the manufacturer. Usually this is biocompatibility data. It cannot be used for a performance endpoint, but biocompatibility data can be used when you are trying to claim a safety endpoint.
Published animal studies. These published animal studies are usually for those devices where it is unethical to have clinical data like establishing that your device accurately performs something. Just to have that data conducting a study on humans, if it is unethical in that scenario, you can use data from animal studies as well.
[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]CAPTIS™ – Our EU MDR & IVDR Technology Solution[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]We have a system at Celegence that we use to handle all of our literature data. One of the major sources of clinical information and in some cases, animal studies or non-clinical testing that is published is via literature search and handling large amounts of data from the literature search is a little difficult. To make this task a lot easier, we have a system within Celegence that we use, which is called CAPTIS™.
It is an automated system that facilitates faster literature reviews, and it helps you perform adverse event analysis as well because this system has the feature to download Total Product Lifecycle (TPLC) data. It has the feature to download adverse event data from MAUDE as well. So, the adverse event analysis, as well as the literature reviews and analysis are a lot easier with the system.
It is integrated with most of the commonly used databases like PubMed, Google scholar, Cochrane, Europe PMC. So, conducting a search on CAPTIS™ is easy and then screening the articles and documenting the L1 & L2 screening. Tagging these articles is also very easy. It’s something that simplifies the process of literature search and considerably reduces the amount of time that you spend on this activity.
It helps for bulk import of search data, and then it automatically imports any free full texts that are available.
There are audit trails for each article, so you can check what has happened with the article from the time when it was searched.
There are also automatic triggers for any report updates, which is very useful when there are multiple people working on a document,
There is a option for optimized data collection and storage.
There are also forms that you can customize based on what you are looking for. In case you are looking for a particular claim or in case you are looking for a particular data set that you require to demonstrate compliance with your claims, tagging those articles, looking for specific keywords. It becomes very simple with this system, and it also accesses a repository for all of the data that you have, not only for a single project but multiple projects.
There is also a correlation that can be done between different searches done on the same device. You can tag the articles and you can define if an article helps you support a specific safety claim. You can define if an article helps you support a specific performance claim, and then you can filter out these articles once you’ve tagged them. Apart from summarizing them under DuE, you can also separately pull out an export for just an article supporting your claims.
You can also create summaries on the CAPTIS™ You can highlight important data that can be referred later on.
You can also have the system where you tag or leave comments for specific people. So, if there are multiple people working on the system, you can leave comments for them.
You can action a particular article based on what you feel is relevant but leave a comment so that everyone is aware of why this action was taken. You can also leave notes on articles.
You can consider devices like stents. For stents, one of the performance objectives that you can consider is successful revascularization. The percentage restenosis or number of revascularization procedures that need to be repeated.
These are directly related to the stents and all of them are quantifiable. So going through the state-of-the-art for a benchmark device, or going through industry standards, you can come up with values that are acceptable against each of these performance criteria.
The same goes for the safety criteria. You can use the industry standards or state-of-the-art data to determine the percentage of dissections, deaths or MIs that can be considered acceptable for the device of interest.
Indirect Benefits
There are two types, one which can claim the benefit of the main device and the second one where you use surrogate endpoints, because you’re claiming a complete indirect benefit. Based on the surrogate endpoints, you are going to demonstrate that your device achieves its intended purpose.
For this example, Guidewires where all the safety and performance benefits are same as those of stents. You can say that my guidewire can be considered as it has successfully performed its intended use if the revascularization is successful. If the number of dissections are within range, then your guidewire can be considered safe. So, you can use the same safety and performance endpoints, although identifying the data becomes a little difficult. But again, you can tag articles based on which particular stents you are considering, which type of device you want specify with use with your guidewire. So, these are things that you can consider while claiming the benefit of the main device.
You can also consider surrogate endpoints. Like I mentioned for devices used for monitoring procedures during ECMO and dialysis, it is important to monitor the flow rate or the blood flow through the system, as well as recirculation and other factors which help to optimize the ECMO and dialysis. Devices which do this activity for them having clinical endpoint through ECMO and dialysis is difficult. So, you can use surrogate endpoints and just say reproducible and accurate measurements of any of these parameters helps the physician optimize ECMO and therefore demonstrating that your device can accurately or reproduce and reproducibly measure these parameters is a surrogate endpoint and therefore it is achieving its clinical benefit.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Notified Body Observations Regarding Claims[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]In our experience, we have received some NB observations on our previous years that surround claims. One of the major observations that we’ve received is that the claims are not measurable or verifiable.
Not measurable verifiable: So, if you make a very generic claim like our device performs well. It is not a measurable or verifiable claim. You must define what you mean by performs well. You must define what clinical condition or what clinical endpoint you are considering, saying that it performs well, and it always must be something that you can demonstrate by our data within the CER.
Technical rather than clinical: We’ve also received observations that say that the clinical claim is more technical rather than clinical. So, saying that my device is easily portable. The size is only XX into XX centimeters. This is a technical claim. It has no direct clinical benefit to the patient, and it is not something that you can demonstrate except to show that this is the design of the device.
These types of claims are not expected to be a part of the CER, you can have them in your technical file, and it could have benefits that it is easily portable or it’s easier to use. But then again, it’s not something that has a clinical benefit and therefore need not be included in the clinical evaluation.
No justification for use of non-clinical data: There are scenarios where devices, which are new or in some cases, devices which have been on the market, but do not have clinical investigations have used non-clinical data to demonstrate compliance with the claims or to demonstrate that the device achieves the claims. In this case, a justification should be provided for why you are using the non-clinical data when it is possible to use clinical data and if this justification is not available, then the use of non-clinical data is not usually allowed by the notified body.
Unless it’s a device where you cannot use clinical data or it’s unethical to conduct clinical experiments for the purpose of demonstrating the endpoint for your device. Only in that case, can you use non-clinical data. So, at any data justification must be added for the use of non-clinical data.
Incorrect identification of endpoints: Another concern has been the incorrect identification of endpoints. So, for example, if I say that my device helps in reducing pain, if I am not producing the pain score that I use, the pain scale that I use to identify if it is actually reducing pain, then it’s not an endpoint that is valid. If I’m not able to demonstrate it via the data that I have, it’s not a valid endpoint and it’s not a measurable endpoint. It’s not an endpoint that I have sufficient data for. So, it is something that the notified body points out during the review of the clinical evaluation.
Not enough clinical data: Another one is not enough clinical data. If the clinical data, you have just say 1 article or a very limited study on a small number of patients for demonstrating a particular claim it will not be considered. It must be statistically relevant and significant data. If it is statistically insignificant, then it is likely going to be rejected by the notified body as not sufficient data for a particular claim.
One important thing to remember is you can say these are claims that are going to be, or that are not currently put on any IFU or any website or any print or media, but they are claims that you’re hoping to demonstrate via PMCF data, which is acceptable, provided it is not already published for your device. The notified body does agree to having those claims within the CER.[/fusion_text][fusion_imageframe image_id=”14327|full” max_width=”” sticky_max_width=”” skip_lazy_load=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Medical Device Claims Conclusions” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/08/Medical-Device-Claims-Conclusions.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Conclusions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Identifying claims creates the objectives of your clinical evaluation, it shows that the device achieves its intended purpose safely – Your first focus while doing a clinical evaluation is to identify the objectives. What are you hoping to demonstrate? Why is this a clinical evaluation? These objectives come from determining the claims that you’re hoping to establish for your device. It is not always necessary that your claims have to be something that is apart from your intended use. You can always say that you claim that your device functions as intended and achieves so and so clinical benefit, and then establish how you’re going to demonstrate that it achieves this clinical benefit, which is a perfectly reasonable claim and an objective to make.
It helps you determine what data is lacking for your device – The next step is to check how much data you have for demonstrating these objectives. Do you have sufficient data? Do you have the right kind of data? Is it clinical? Is it non-clinical? Is it going to be accepted? If you have only non-clinical data, is there a reason? Is it something that you will be able to justify?
Determining the medical benefits and identifying the expected clinical outcomes makes it easier to demonstrate the acceptability of the benefit-risk profile of the device.
This exercise helps to identify any holes in the information provided with the device and the risk management process currently in place.
If you do not have enough data to demonstrate a particular claim, or if you do not have enough data to demonstrate any of the objectives that you have identified. Then you have to reevaluate if you are claiming the right things, does your device need or design change? or does it need reevaluation to make sure that it in fact demonstrates these claims? Or is it just that you must rephrase the claims in such a way that you can demonstrate it via the data that you have. So doing this entire process of identifying your claims and checking the amount of data that you have should be done at the very beginning of a clinical evaluation, because it does result in change of the IFU in certain cases making sure that the verbiage is not something that can mislead the user or the patient.
So doing this at the very beginning of your clinical evaluation, before you start drafting the CER, before you even start putting in all of the data is a very good practice and that is how we work at Celegence to make sure that we have all the data in place before starting off the clinical evaluation, just so that we don’t go back and change the IFU or the operator manual, which results in a change of the entire evaluation process, where you have to go back and rerun the searches and redo everything. So, to avoid that rework, it is best to do this at the very beginning of your clinical evaluation.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ 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fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Celegence provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers. Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” 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In MEDDEV 2.7/1 rev 4 , the significance of a systematic review is constantly emphasized as being essential to ensure compliance with the new EU MDR and EU IVDR. With carefully crafted research questions, a systematic literature review is a structured and objective method that locates, evaluates, and analyses clinical evidence. To find all literature sources pertinent to the Clinical Background, State of the Art (SotA), and the subject device, a thorough, methodical search of databases like PubMed, Embase, Cochrane, Google Scholar etc. is required.
In this article we’ll outline how the Google Scholar Integration within CAPTIS™ can allow you and your team to produce higher quality Systematic Literature Reviews with greater accuracy.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Systematic Literature Review Stages[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
The first stage (Level 1) in a systematic literature review involves taking inclusion or exclusion decisions based on the information in the Title and Abstract of the article. This step serves as a checkpoint for identifying articles which may contain evidence for your search objective. Articles included in the first stage then undergo a full-text evaluation (Level 2), where a detailed qualitative appraisal and analysis of the article takes place.
[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][wd_hustle id=”18″ type=”embedded”/][/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” 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highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Limited Information in Abstracts[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Article abstracts typically do not provide the entire information on the materials, equipment and devices used in the research, which is expected, since the abstract is a short summary of the research. Now if your device of interest is the primary focus of a clinical study, it quite likely will secure a place in the abstract, like the lead actors in a movie poster. Hence, the presence of the device is easily detected, and the article is included (assuming all other inclusion parameters are satisfied). This works well for devices which are a topic of popular research.
Now what if your subject device had an ancillary role in the treatment? Say, the owner of the café who hands the details of the next mission on a napkin to the main lead in an action movie; surely an important scene, but not critical enough to make it to the movie poster. Likewise, low risk medical devices are unlikely to have clinical studies dedicated to them, and often do not enjoy the same stardom and mention in the abstracts like their higher-risk/popular associates in the treatment. For example, the abstract of a clinical study comparing the clinical outcomes of various customized orthodontic brackets most likely will not mention the archwire, adhesives, or other devices used in the treatment.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Study Objective
Comparison of the clinical effects of different customized orthodontic brackets
Main Device (primary focus of the research)
Custom CAD/CAM Orthodontic Brackets
Ancillary Devices (not the focus of the research)
Etchant, Primer, Adhesives, Curing Light, Archwire, Ligatures, Dental Bands, Relief Wax, Probes, Pliers etc.
While direct clinical evidence (wherein main study outcomes are on the device of interest) is sought-after and essential for high-risk devices, indirect clinical evidence (where study outcomes are not based on the device of interest, but the device was a part of the treatment) is also valuable for demonstrating the safety and/or performance of the device especially when direct literature evidence is scarce.
Since full-text evaluation is done after the articles pass the title and abstract screening stage, there are chances you may mistakenly exclude a relevant paper because your device wasn’t mentioned in the title and abstract of the study. And even if the “device type” is mentioned in the abstract, if it wasn’t the primary focus of the study, the brand name or manufacturer of the device may not be mentioned, which leads to another level of review to ensure that the study used your brand or manufacturer of interest.
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box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]What makes Google Scholar special?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Google Scholar is a freely accessible search engine which provides a simple way for researchers to broadly search for scholarly literature using the keywords of their research projects. Unlike research databases such as PubMed, Google Scholar conducts its searches across all internet sources, even within the full text of paid articles and can return much more diverse results.
Low-risk devices which are unlikely to be the primary focus of a clinical research often suffer from low results from literature since most databases will not scan the full-text of the article for the keywords, nor will the title and abstract mention the devices. In scenarios like these, indirect clinical evidence is also valuable.
Google Scholar searches the entirety of the scholarly work for the keywords that you search for and returns the snippet from the full text which contains the searched keywords. Hence, with the correct combinations of search operators and keywords, you can find clinical studies using your device of interest even if the device was not mentioned in the abstract. Google Scholar will also notify you of the presence of your keyword in the article, even if the article is not open access (yes, we’re amazed too).[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]PubMed vs Google Scholar[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]
Take a look at the results from PubMed vs Google Scholar for the same search parameters:
[/fusion_text][fusion_imageframe image_id=”14188|full” max_width=”” sticky_max_width=”” skip_lazy_load=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Pubmed vs Google Scholar” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/08/PubMed-Google-Scholar-Integration-Celegence.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Figure 1: Search results from PubMed[/fusion_text][fusion_imageframe image_id=”14191|full” max_width=”” sticky_max_width=”” skip_lazy_load=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Google Scholar Integration – Systematic Literature Review” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/08/Google-Scholar-Integration-Systematic-Literature-Review.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Figure 2: Search results from Google Scholar for the same keywords and search filters. The text below the Title and Authors is not the abstract, but a “snippet” from the full text containing the searched keywords. [/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Advantages and Disadvantages of using Google Scholar[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The Benefits
At its core, Google Scholar is simply a search engine. One of the major advantages of using Google Scholar is that searches for keywords are conducted within the full text of articles and returned as snippets from the same, meaning it not only helps researchers find very specific results relevant to the device of interest, but , which wouldn’t have been visible in a standard Level 1 review.
Google Scholar searches the full text of both open access and paid research articles, and other related information from across the internet and is not limited to title and abstract searching only, giving you more results to consider for your Level 1 review, which ultimately leads to a better CER or PER.
Does this mean you shouldn’t use databases such as PubMed? No, that’s not the case; PubMed, Embase and other research databases play a critical role in every review, especially with regards to the quality of the evidence.
The Challenges
With over 100 million records, it certainly is a powerful research tool.
However, the disadvantage of this search engine is that search results also include Grey Literature; considered as materials or research produced by organizations outside of traditional commercial or academic publishing and distribution channels. Common grey literature publication types include reports, working papers, government documents, white papers and evaluations. Grey Literature often does not contain the highest quality of evidence and will likely be excluded; however, this is not necessarily a disadvantage if you want to include certain grey literature items in your final reports.
Moreover, search results obtained from Google Scholar are not easy to extract from the search engine (when compared to direct exports from databases like PubMed and Embase). The extraction activity requires a significant amount of manual effort which could negatively impact your timeline in terms of effort and can often be an error-prone task.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Google Scholar Integration Within CAPTIS™[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]At Celegence, we understand operational challenges faced by device manufacturers and medical writers alike and use technology to overcome these challenges. Hence, we integrated the Google Scholar search and extraction feature within the CAPTIS™ platform. You can now retrieve data directly from Google Scholar in an efficient manner without any extra manual input.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]CAPTIS™ Makes it Easier to Use Google Scholar[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]To search on Google Scholar within the CAPTIS™ platform, you simply need to enter the Google Scholar search string, filters and run the query. CAPTIS™ matches the Google Scholar results with entries on other databases likes PubMed (where applicable) and returns all the information medical writers need for their Level 1 Screenings – title, abstract and publication details, along with additional information such as hyperlinks, snippets, keywords, descriptors, and publication type which normal Google Scholar searches outside of the CAPTIS™ platform do not give.
What’s more, you can export all CAPTIS™ results into an RIS file for easy imports to a Reference Management Software such as EndNote, Mendeley, Zotero and others.[/fusion_text][fusion_imageframe image_id=”14192|full” max_width=”” sticky_max_width=”” skip_lazy_load=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align_medium=”none” align_small=”none” align=”none” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Google Scholar Integration CER CEP- Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2022/08/Google-Scholar-Integration-CER-CEP-Celegence.jpg[/fusion_imageframe][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Figure 3: Screenshot of a Google Scholar result from CAPTIS™[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Benefits of using Google Scholar (GS) within CAPTIS™[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Here are some of the benefits of using the Google Scholar Search feature within CAPTIS™:
Automatic and easy extraction of detailed search results
Article mapping with other databases for additional information
Offers resource efficiency
Offers cost efficiency
Allows rapid extraction of full texts
Access to a substantial body of grey literature as well as academic literature
Easy export of bulk or single citations to an external Reference Management tool
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