An Academic presentation byDr. Nancy Agnes, Head, Technical Operations, Pubrica Group: www.pubrica.comEmail: sales@pubrica.com

SYSTEMIC REVIEWS ON IMPLANTABLE MEDICAL DEVICES PROVIDE A QUALITY OF REPORTING

Today's Discussion

In-Brief IntroductionDefining Active Implantable Medical Devices Literature SearchEligibility Criteria and Citation Screening Data ExtractionRecommendations of Reporting Items for Systemic Reviews of Implantable Medical DevicesConclusion

Outline

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.

IntroductionIn 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(FDA), these

the Foodand Drug Administration are devices that arepartially orimplanted 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 currentstrengths, limitations, deficiencies, and uniquechallenges and make recommendations

forfuture

conduct and reporting.

They chose to focus on five broad categories ofimplantable medical devices basedon recommendations ofthe Technical

Expert

the Panel(TEP) and to ensure inclusion of the most commonly

used and expensive devices: cardiac implantable devices, vascular interventional devices, orthopaedic implants, skin-replacement grafts, and neurostimulators.

Defining Active Implantable Medical Devices

An active medical device operates by usingand converting a large amount of energy.

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 Citation Screening

Many publishedsystematicreviews ofimplantable medical devices did not explicitly report all three fundamental components during full-text screening.

Because thecharacteristics,

goalwas to itincluded

assessreporting reviews

ofany

implantable device from any 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).

There are currently no defined techniques or 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.

Data Extraction

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...

Recommendations of Reporting Items for Systemic Reviews of Implantable Medical Devices

Device type

This project would encourage academics to report systematicreviews of implantable medical devices more accurately and transparently.

Also, propose adding eight new device- and operator-specific topics tothe extension guide unique to implantable medical device studies.

Cardiac defibrillators with or without pacemakers

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

devicesFixation and supplementary materials such as plates and screws Contd...

Type of device coating

Skin-replacement grafts

Type of skin graft required

Composition of graft

Graft type: bioabsorbable or requiring removal

Stimulation parameters

frequency intensitypulse width

Electrode location

Neurostimulators

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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