6. Clinical background, current knowledge, state of the art
Source: CER Template.pdf pages 15-17 (document: Mantra Systems Free CER Template, Edition 2)
This section is intended to:
- Provide clinical context to the subject device
- Determine the State of the Art
- Enable the determination of specific safety and performance objectives.
The latter will be used as a benchmark against which safety and performance of the subject device will be measured.
This section should comprise a summary of a State of the Art (SOTA) evidence review. Preferentially, this will be presented as a separate SOTA Protocol & Report document and comprises an evidence-based exploration of the clinical condition and the range of treatments available (with relative advantages and disadvantages).
6.1. Introduction
- What is the status of the individual(s) who performed the search?
- When was the search performed?
6.2. Objective
Describe the objective of the literature search.
6.3. Research questions & search terms
Set out research questions that the Review aimed to address. These should adopt a recognised format, e.g. PICO.
Following determination of research questions, outline specific search terms used to address the research questions. Remember that search parameters must be specified (dates, databases searched, timeframe of the search, etc) and that all excluded sources must be accounted for. Record the number of initial and relevant (included) results against each search term.
6.4. General description of the medical condition
What is the medical field of the device? What medical conditions are being treated/addressed? Summarise the medical condition sufficiently to enable a non-specialist reviewer to understand the target disease and its clinical context. A full version of this summary should be presented in the separate SOTA Report.
Populate the section using sources identified via literature review, citing sources throughout. Avoid "naked opinions" and unsubstantiated claims.
6.5. Available treatment options - similar devices and comparable alternatives to the subject device
Describe what other options exist for the treatment / diagnosis / management of the target condition / patient population. Summarise appraised clinical evidence (presented in full in a separate SOTA Report) and draw conclusions to build a narrative.
6.5.1. Safety and performance objectives
Conclude the subsection on alternative treatments by defining clinical outcome parameters and safety and performance objectives.
Clinical outcome parameter = qualitative outcome relating to device safety or performance appearing in multiple SOTA sources in a comparable form
- e.g.: "Reduction in pain VAS"
- e.g.: "Increase in walking distance"
Safety / performance objective = quantitative benchmark derived from a weighted mean of multiple results relating to a clinical outcome parameter. Forms a quantitative objective that the subject device must be at least non-inferior to.
- e.g.: (reduction in pain VAS) 4.8 (cm)
- e.g.: (increase in walking distance) 16 (metres)
It is also necessary to outline parameters for determining the acceptability of the benefit-risk profile of the subject device by referencing specific evidence-based outcomes seen in comparable alternatives.
Data analysis and formation of safety / performance objectives is a complex aspect of writing any CER and a common area of non-conformity. For assistance in conducting meta-analyses and forming safety and performance objectives, please contact a member of our team.
6.6. State of the art
State of the art is defined in MedDev 2.7/1 rev 4 as:
"The state of the art embodies what is currently and generally accepted as good practice. The state of the art does not necessarily imply the most technologically advanced solution."
Therefore, this subsection should consolidate the information outlined in the preceding sections to determine what is currently accepted as good practice in the clinical field. Focus should be placed on authoritative guidelines (such as NICE Guidelines) outlining evidence-based positions on current practice.