Systemic reviews on implantable medical devices provide a quality of reporting – Pubrica
                     SYSTEMIC REVIEWS 
ON  IMPLANTABLE 
MEDICAL  DEVICES 
PROVIDE A  QUALITY 
OF REPORTING
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica 
 Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outline In-Brief  
Introductio
n
Defining Active Implantable Medical 
Devices  Literature Search
Eligibility Criteria and Citation 
Screening  Data Extraction
Recommendations of Reporting Items for 
Systemic  Reviews of Implantable Medical 
Devices
Conclusion
In-Brief
Even though there have been many systematic reviews of implantable medical 
 devices published, no empirical evaluation of the reviews has been done. To  
understand the methodology utilized, identify existing strengths, limitations,  
flaws, and specific issues, and provide recommendations to enhance future  
conduct and reporting, we undertook a critical appraisal of the quality of  
reporting in systematic reviews of implanted medical devices. These  
characteristics may have an impact on the study outcomes.
Introduction
In medical practice and research, systematic reviews  
service have a well-established place.
Clinicians utilize systematic reviews to stay up to date  
on current research and compare the efficacy of  
competing therapies.
Although many systematic evaluations of medical  
devices have been published, no empirical evaluation  
of the reviews has been conducted.
Contd...
The findings of an empirical evaluation of systematic  
reviews of medical devices could be utilized to design  
new reporting rules and improve the conduct and  
quality of systematic reviews of medical devices  
reporting.
The Consolidated Standards of Reporting Trials  
(CONSORT) Statement was recently updated to  
include trials of non-pharmacological treatments;  
however, there are still no recommendations for  
systematic evaluation of medical devices. Implantable 
 medical devices are one big group of devices of  
interest.
Contd...
According to theFoodand Drug Administration  are
(FDA), these devices that are partially or
implanted into the body or a natural orifice via surgical 
 or medical procedures and are intended to remain in  
the body or orifice for at least 30 days, according to  
the Food and Drug Administration (FDA) (or  
permanently).
Such devices can only be physically removed or  
medically deactivated. Implantable devices can also  
be utilized to replace an epithelium or ocular surface.
Contd...
The market for implantable medical devices in the 
 United States is expected to expand 8.3% year to 
$49  billion, with spinal implants, cardiac implants, 
and  orthobiologics being the fastest-growing 
categories  (substances that accelerate healing of 
injured bones).
Here assumed a critical appraisal of the quality of 
 reporting in systematic reviews of implanted medical  
devices as the Evidence-based Practice Center  
(EPC) designated for the crosscutting concentration 
 of diagnostic testing, imaging technologies, and  
medical and assistive devices.
Contd...
The project's objectives were to assess published  
systematic reviews and meta-analyses to understand  
better the methodologies used and identify current
strengths, limitations, deficiencies, and unique
challenges and make recommendations future
conduct and reporting. for
They chose to focus on five broad categories of
implantable medical devices based the 
on  recommendations ofthe Technical  
E(TxEpPe)rt and to ensure inclusion of the most commPoannlye l 
used and expensive devices: cardiac implantable  
devices, vascular interventional devices, orthopaedic  
implants, skin-replacement grafts, and  
neurostimulators.
Defining  
Active  
Implantable An active medical device operates by usingand  converting a large amount of energy.
 Medical  
Devices Except for gravitational and direct humanenergies,  active devices can use any energy.
Active medical devices, as defined by the Therapeutic  
Goods (Medical Devices) Regulations 2002, can be  
broadly classified into two categories:
Contd...
The manufacturer intends for active medical devices for diagnosis to be used on a  
human being to provide information for detecting, diagnosing, monitoring, or treating  
physiological conditions, states of health, illnesses, or congenital deformities, either  
alone or in combination with another medical device.
The manufacturer intends for active medical devices for therapy to be used on a  
human being to maintenance, modify, replace, or restore biological functions or  
structures to treat or alleviate an illness, injury, or handicap, either alone or in 
 combination with another medical device.
Literature 
 Search
Systematic reviews published between January 2009  
and December 2010 were found using keywords for  
each of the five categories of implantable medical  
devices in MEDLINE® and the Cochrane Database of  
Systematic Reviews.
Articles with abstracts that described searches or  
eligibility criteria for study identification or included  
terms like "systematic," "evidence," "evidence-based,"  
"meta-analysis," or "pooled analysis" were considered  
potentially relevant reviews.
Eligibility  
Criteria 
and  Many publishedsystematicreviews of
implantable medical devices did not explicitly  
Citation  report all three fundamental components during  
Screening full-text screening.
Because the goal was assess reporting  
characteristics, to  it reviews of any
implantable devicien cfrloumde adny of the five categories 
 that looked at a recent publication.
Contd...
Contd...
For example, a review of a pacemaker, a review of 
 a defibrillator, or a review of both a pacemaker 
and  a defibrillator might be included in the cardiac  
implantable device category.
Systematic reviews of any type (randomized trials,  
non-randomized comparative studies, or  
observational research), as well as synthesis  
technique, were considered (qualitative or  
quantitative synthesis including meta-analyses of  
individual patient data).
Data  
There are currently no defined techniques or  Extraction
protocols for assessing the quality of systematic  
reviews of implantable medical devices reporting.
Here examined the TEP to identify device- and  
operator-specific information relevant to these  
devices' evaluation.
In addition to the 30 systematic reviews, specific  
information items described in the MOOSE and  
PRISMA recommendations have found eight  
device- and operator-specific information items.
Recommendations of Reporting Items for 
Systemic  Reviews of Implantable Medical 
Devices
Reporting of device or procedure-specific data
PROSPERO—the International Prospective Register of Systematic Reviews—also  
offers systematic review reporting, conduct, scientific writing, and publication through  
a formal protocol registration process.
At the time of registration of systematic review protocols, propose include eight new  
device- and operator-specific elements unique to implanted medical device research.
Contd...
This project would encourage academics to report systematic
reviews of  implantable medical devices more accurately and transparently.
Also, propose adding eight new device- and operator-specific topics to
the  extension guide unique to implantable medical device studies.
Cardiac defibrillators with or without pacemakers
Device type Contd...
Contd...
Method of implantation
Position of the electrode
Description of microprocessor technology and programmable features 
 Alert features that monitor lead impedance
Vascular interventional devices (e.g., stents)
Contd...
Type of stent and stenting technique
Generation of the stent (e.g., first or second generation) 
 Type of antiproliferative drug used
Delivery system 
 Polymer layer
Contd...
Stent frame
Orthopaedic implants 
 Type of device
Surgical technique or approach 
 Number and location of 
dFeixvaictieosn and supplementary materials such as plates and screws Contd...
Type of device coating Neurostimulators
Skin-replacement grafts Stimulation parameters
Type of skin graft required frequency 
 intensity
Composition of graft pulse 
width
Graft type: bioabsorbable or requiring removal Electrode location
Conclusion
The lack of reporting of some essential general items  
applicable to any systematic review and device- and  
operator-specific information is revealed in a review of  
systematic reviews on implantable medical devices.
Eight device- or operator-specific items were also  
identified as potentially useful in reporting on  
systematic reviews of implanted devices and might be  
included in reporting recommendations.
Contd...
In recent years, the number of systematic evaluations  
of implantable medical devices has increased  
dramatically, with reviews appearing in a wide range of 
 journals.
Failure to include data on procedures and devices  
could lead to incorrect synthesis or interpretation of  
results because there is no widely acknowledged  
standard for reporting information to implantable  
medical device research.
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